EPA (Environmental Protection Agency)
4 records
fda
705 records
FDA Recall: Zimmer Biomet, Inc. — Class II
20201230
Device has the potential for fracture during use. | Product: Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage:
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20201111
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual steril | Product: ZCA All Poly Acetabular Cup Longevity ...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20201111
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual steril | Product: ZCA All Poly Acetabular Cup Longevity ...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20201111
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual steril | Product: ZCA All Poly Acetabular Cup Longevity ...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20201111
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual steril | Product: ZCA All Poly Acetabular Cup Longevity ...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20201111
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual steril | Product: ZCA All Poly Acetabular Cup Longevity ...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20201111
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual steril | Product: ZCA All Poly Acetabular Cup Longevity ...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20201111
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual steril | Product: ZCA All Poly Acetabular Cup Longevity ...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20201111
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual steril | Product: ZCA All Poly Acetabular Cup Longevity ...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20201111
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual steril | Product: ZCA All Poly Acetabular Cup Longevity ...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20201111
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual steril | Product: ZCA All Poly Acetabular Cup Longevity ...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20201111
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual steril | Product: ZCA All Poly Acetabular Cup Longevity ...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20200610
There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-opera | Product: Vital MIS Spinal Fixation system impla...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20200610
There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-opera | Product: Vital MIS Spinal Fixation system impla...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20200610
There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-opera | Product: Vital MIS Spinal Fixation system impla...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20200610
There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-opera | Product: Vital MIS Spinal Fixation system impla...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20200610
There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-opera | Product: Vital MIS Spinal Fixation system impla...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20200610
There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-opera | Product: Vital MIS Spinal Fixation system impla...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20200304
Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packagi | Product: THP Hip Plating System, Item Nos. 14-4...
View Source
FDA Device Recall: Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutt
2020-12-30
Class II — Device has the potential for fracture during use.
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neu
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 d
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 d
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neut
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 d
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 d
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neu
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neut
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 d
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 d
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 d
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neut
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 d
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neu
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22mm, Neutr
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neut
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 d
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 d
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 d
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neu
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neut
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 d
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 d
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neut
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 d
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32mm, Neutr
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neut
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neu
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 d
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 d
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 d
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neut
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 d
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neut
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 d
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 d
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neut
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neut
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 d
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 d
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neut
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neut
2020-11-11
Class II — Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for...
View Source
FDA Device Recall: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM, Item Numbe
2020-06-10
Class II — There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
View Source
FDA Device Recall: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X45MM, Item Numbe
2020-06-10
Class II — There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
View Source
FDA Device Recall: Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, Item Number
2020-06-10
Class II — There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
View Source
FDA Device Recall: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM, Item Numbe
2020-06-10
Class II — There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
View Source
FDA Device Recall: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X45MM, Item Numbe
2020-06-10
Class II — There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
View Source
FDA Device Recall: Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X60MM, Item Number
2020-06-10
Class II — There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
View Source
FDA Device Recall: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X40MM, Item Numbe
2020-06-10
Class II — There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
View Source
FDA Device Recall: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X55MM, Item Numbe
2020-06-10
Class II — There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
View Source
FDA Device Recall: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X35MM, Item Numbe
2020-06-10
Class II — There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
View Source
FDA Device Recall: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X45MM, Item Numbe
2020-06-10
Class II — There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
View Source
FDA Device Recall: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X30MM, Item Numbe
2020-06-10
Class II — There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
View Source
FDA Device Recall: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X55MM, Item Numbe
2020-06-10
Class II — There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
View Source
FDA Device Recall: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X35MM, Item Numbe
2020-06-10
Class II — There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
View Source
FDA Device Recall: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X40MM, Item Numbe
2020-06-10
Class II — There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
View Source
FDA Device Recall: THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14
2020-03-04
Class II — Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging.
View Source
FDA Device Recall: Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model N
2020-02-12
Class II — The lot contained two outer pins instead of one outer and one inner pin.
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FDA Recall: Zimmer Biomet, Inc. — Class II
20191204
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | Product: COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 11533...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20191204
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | Product: BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20191204
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | Product: BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: Th...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20191204
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | Product: Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-16281...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20191113
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Product: BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 004...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20191113
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Product: Connection Screw for NCB Plate, Item No. 0202266002
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FDA Recall: Zimmer Biomet, Inc. — Class II
20191113
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Product: PERIARTICULAR PLATES - FEMUR, Item Nos. 00234700106 00234700108 00234700110 00234700112 00234...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20191113
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Product: Various Knee Systems, Item Nos. 32855411838 32855411840 32855411842 32855411843 32855420307 ...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20191113
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Product: Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Item Nos. 47235700306 47235700308 472357...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20191113
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Product: Metasul Femoral Heads, various sizes, Item Nos. 00877004001 00877004002 00877004003 0087700400...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20190918
The locking bar not fully engaging | Product: XP-XP Tibial Tray - Interlok 79 mm Item # 195758
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FDA Recall: Zimmer Biomet, Inc. — Class II
20190918
The locking bar not fully engaging | Product: XP-XP Tibial Tray - Interlok 65 mm Item # 195752
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FDA Recall: Zimmer Biomet, Inc. — Class II
20190918
The locking bar not fully engaging | Product: XP-CR Tibial Tray - Porous Plasma 91 mm Item # 195291
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FDA Recall: Zimmer Biomet, Inc. — Class II
20190918
The locking bar not fully engaging | Product: Vanguard XP Tibial Tray 75 mm Item # 195251
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FDA Recall: Zimmer Biomet, Inc. — Class II
20190918
The locking bar not fully engaging | Product: XP-XP Tibial Tray - Interlok 59 mm Item # 195750
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FDA Recall: Zimmer Biomet, Inc. — Class II
20190918
The locking bar not fully engaging | Product: Vanguard XP Tibial Tray 63 mm Item # 195245
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FDA Recall: Zimmer Biomet, Inc. — Class II
20190821
Cleaning processes potentially being ineffective | Product: Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151812
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FDA Recall: Zimmer Biomet, Inc. — Class II
20190821
Cleaning processes potentially being ineffective | Product: Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151811
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FDA Recall: Zimmer Biomet, Inc. — Class II
20190710
There is a potential for weak seals of the sterile packaging. | Product: DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposa
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FDA Recall: Zimmer Biomet, Inc. — Class II
20190710
There is a potential for weak seals of the sterile packaging. | Product: DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: These DVR Express Disposab
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FDA Recall: Zimmer Biomet, Inc. — Class II
20190612
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion. | Product: Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femora...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20190313
The product was potentially being packaged without a taper adapter. | Product: Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 01
View Source
FDA Device Recall: Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual s
2019-12-11
Class II — Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam
View Source
FDA Device Recall: COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S
2019-12-04
Class II — Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
View Source
FDA Device Recall: BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097
2019-12-04
Class II — Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
View Source
FDA Device Recall: BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usag
2019-12-04
Class II — Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
View Source
FDA Device Recall: Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-
2019-12-04
Class II — Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
View Source
FDA Device Recall: HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit
2019-12-04
Class II — Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
View Source
FDA Device Recall: Comprehensive RS Cleat CAP, Item No. 110300
2019-12-04
Class II — Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
View Source
FDA Device Recall: ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomiu
2019-12-04
Class II — Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
View Source
FDA Device Recall: LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL-
2019-12-04
Class II — Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
View Source
FDA Device Recall: HENNESSY LEFT CONST GLENOID HA, Item No. PM555360 UDI (01)00880304819597(17)260
2019-12-04
Class II — Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
View Source
FDA Device Recall: Various Custom Products, Item Nos. CP102940 CP102941 CP102942 CP102943 CP102
2019-12-04
Class II — Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
View Source
FDA Device Recall: BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: Connection Screw for NCB Plate, Item No. 0202266002
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: PERIARTICULAR PLATES - FEMUR, Item Nos. 00234700106 00234700108 00234700110 0
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: Various Knee Systems, Item Nos. 32855411838 32855411840 32855411842 328554118
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Item Nos. 47235700306 47
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: Metasul Femoral Heads, various sizes, Item Nos. 00877004001 00877004002 008770
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263009
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: Various temporary devices used during the implantation of the device system: bon
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: Ceramic Femoral Heads, various sizes, Item Nos. 00877504001 00877504002 008775
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: Various fixation systems and accessories, Item Nos. 00118100522 00118100527 00
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: PROX LAT HUMERAL LOCK PLATE, Item Nos. 47235800104 47235800106 47235800108 47
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: Various fixation systems and accessories, Item Nos. 00224000916 00224000918 00
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: LPS-MOB ART SURF IMPL D 9MM
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: ZPLP Fibular Plate, Item Nos. 00234701504 00234701506 00234701508 00234701510
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492800
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 005
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 00234700308
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: NCB-PH Plate with 4/5/7 Lock Holes, Item Nos. 0202262104 0202262105 0202262107
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: DIST LAT FEM LCK PLATE STERILE, Item Nos. 47235710106 47235710110 4723571011
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: Cephalomedullary Nail (CMN), Various sizes, Item Nos. 47249318009 47249318010
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 0058500120
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 002
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: NCB Straight Narrow Plate, various sizes, Item Nos. 0202267008 0202267010 0202
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: FEMOROTIBIAL/FEMORAL NAIL, various sizes. Item Nos. 32855331111 32855331113 32
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: cable button for NCB¿ Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 472232
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 0100296050
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201 002232002
2019-11-13
Class II — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
View Source
FDA Device Recall: XP-XP Tibial Tray - Interlok 79 mm Item # 195758
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: XP-XP Tibial Tray - Interlok 65 mm Item # 195752
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: XP-CR Tibial Tray - Porous Plasma 91 mm Item # 195291
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: Vanguard XP Tibial Tray 75 mm Item # 195251
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: XP-XP Tibial Tray - Interlok 59 mm Item # 195750
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: Vanguard XP Tibial Tray 63 mm Item # 195245
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: XP-CR Tibial Tray - Interlok 75mm Item # 195275
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: XP-CR Tibial Tray - Interlok 87 mm Item # 195278
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: Vanguard XP Tibial Tray 73 mm Item # 195250
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: XP-XP Tibial Tray - Interlok 83 mm Item # 195759
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: XP-XP Tibial Tray - Interlok 73 mm Item # 195756
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: XP-CR Tibial Tray - Interlok 91 mm Item # 195279
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: Vanguard XP Tibial Tray 79 mm Item # 195252
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: Vanguard XP Tibial Tray 67 mm Item # 195247
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: XP-CR Tibial Tray - Interlok 83 mm Item # 195277
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: XP-XP Tibial Tray - Interlok 69 mm Item # 195754
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: Vanguard XP Tibial Tray 65 mm Item # 195246
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: XP-CR Tibial Tray - Interlok 63mm Item # 195269
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: XP-XP Tibial Tray - Interlok 67 mm Item # 195753
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: Vanguard XP Tibial Tray 69 mm Item # 195248
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: XP-XP Tibial Tray - Interlok 75 mm Item # 195757
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: XP-CR Tibial Tray - Interlok 71mm Item # 195273
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: XP-CR Tibial Tray - Interlok 65mm Item # 195270
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: XP-CR Tibial Tray - Interlok 73mm Item # 195274
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: XP-CR Tibial Tray - Interlok 79 mm Item # 195276
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: XP-XP Tibial Tray - Interlok 63 mm Item # 195751
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: Vanguard XP Tibial Tray 71 mm Item # 195249
2019-09-18
Class II — The locking bar not fully engaging
View Source
FDA Device Recall: Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151812
2019-08-21
Class II — Cleaning processes potentially being ineffective
View Source
FDA Device Recall: Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151811
2019-08-21
Class II — Cleaning processes potentially being ineffective
View Source
FDA Device Recall: Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151815
2019-08-21
Class II — Cleaning processes potentially being ineffective
View Source
FDA Device Recall: Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810
2019-08-21
Class II — Cleaning processes potentially being ineffective
View Source
FDA Device Recall: Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151813
2019-08-21
Class II — Cleaning processes potentially being ineffective
View Source
FDA Device Recall: Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151814
2019-08-21
Class II — Cleaning processes potentially being ineffective
View Source
FDA Device Recall: Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage:
2019-07-24
Class II — The products do not have sufficient data to support the labeled shelf life of 10 years.
View Source
FDA Device Recall: Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), I
2019-07-24
Class II — Lack of an adequate sterilization validation.
View Source
FDA Device Recall: Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item u
2019-07-24
Class II — The products do not have sufficient data to support the labeled shelf life of 10 years.
View Source
FDA Device Recall: Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), I
2019-07-24
Class II — Lack of an adequate sterilization validation.
View Source
FDA Device Recall: DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These
2019-07-10
Class II — There is a potential for weak seals of the sterile packaging.
View Source
FDA Device Recall: DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: These
2019-07-10
Class II — There is a potential for weak seals of the sterile packaging.
View Source
FDA Device Recall: K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express
2019-07-10
Class II — There is a potential for weak seals of the sterile packaging.
View Source
FDA Device Recall: Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Nu
2019-06-12
Class II — Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
View Source
FDA Device Recall: Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Nu
2019-06-12
Class II — Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
View Source
FDA Device Recall: Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Sp
2019-06-12
Class II — Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.
View Source
FDA Device Recall: T7 Driver Cannulated AO (Part Number 110018531) Product Usage: The Biomet He
2019-05-15
Class II — There is a potential of fracture, bending or shearing of the driver.
View Source
FDA Device Recall: Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titaniu
2019-04-10
Class II — Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.
View Source
FDA Device Recall: Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titaniu
2019-04-10
Class II — Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.
View Source
FDA Device Recall: Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adap
2019-03-13
Class II — The product was potentially being packaged without a taper adapter.
View Source
FDA Device Recall: Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764
2019-03-06
Class II — Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
View Source
FDA Device Recall: Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 Pr
2019-01-23
Class II — There is a potential for silicone shedding during cleaning and sterilization.
View Source
FDA Device Recall: Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Product
2019-01-16
Class II — One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) con...
View Source
FDA Device Recall: Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Us
2019-01-16
Class II — One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) con...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20181219
Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder Sy | Product: Orthopedic Salvage System (OSS) Porous...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20181212
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility | Product: Zimmer ZMS¿ Intramedullary Fixation Smooth Guide ...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20181212
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility | Product: Zimmer M/DN¿ Intramedullary Fixation Humeral Guid...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20181212
Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted | Product: Biomet 20mm Compress Device Short Anchor Plug With Drill Set / Wit...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20181212
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility | Product: Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Dia...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20181212
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility | Product: Zimmer ZMS¿ Intramedullary Fixation Smooth Guide ...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20181128
Label on the outer carton or the patient labels does not match label on the inner sterile packaging | Product: Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20181121
The set screw is not able to advance or reverse from the original position in the nail. | Product: Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus Hip Fracture Nail
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20181121
The set screw is not able to advance or reverse from the original position in the nail. | Product: Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20181114
There is a potential for comingling of the 43MM and 51 MM molds | Product: StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds a
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20181114
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. | Product: Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-103
View Source
FDA Recall: Zimmer Biomet, Inc. — Class I
20181107
Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met. | Product: EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable B...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20181024
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | Product: Affixus Hip Fracture Nail Right 130 11 mm x 340 mm, Item Number 8145113...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20181024
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | Product: Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 8143134...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20181024
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | Product: Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number 81441326...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20181024
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | Product: Affixus Hip Fracture Nail Right 125 11 mm x 440 mm, Item Number 8143114...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20181024
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | Product: Affixus Hip Fracture Nail Right 125 11 mm x 460 mm, Item Number 8143114...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20181024
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | Product: Affixus Hip Fracture Nail Right 125 13 mm x 180 mm, Item Number 8143131...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20181024
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | Product: Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 81461136...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20181024
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | Product: Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number 814409440...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20181024
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | Product: Affixus Hip Fracture Nail Left 125 11 mm x 360 mm, Item Number 81441136...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20181024
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | Product: Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number 81430932...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20180919
The set screw is not able to advance or reverse from the original position in the nail. | Product: Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 440 mm, Item Number: 814309440
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20180919
The set screw is not able to advance or reverse from the original position in the nail. | Product: Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 460 mm, Item Number: 814309460
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20180919
The set screw is not able to advance or reverse from the original position in the nail. | Product: Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 460 mm, Item Number: 814513460
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20180919
The set screw is not able to advance or reverse from the original position in the nail. | Product: Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 360 mm, Item Number: 814411360
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20180919
The set screw is not able to advance or reverse from the original position in the nail. | Product: Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 280 mm, Item Number: 814511280
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20180919
The set screw is not able to advance or reverse from the original position in the nail. | Product: Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 360 mm, Item Number: 814611360
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20180919
The set screw is not able to advance or reverse from the original position in the nail. | Product: Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 400 mm, Item Number: 814515400
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20180919
The set screw is not able to advance or reverse from the original position in the nail. | Product: Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 400 mm, Item Number: 814611400
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20180919
The set screw is not able to advance or reverse from the original position in the nail. | Product: Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 360 mm, Item Number: 814509360
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20180919
The set screw is not able to advance or reverse from the original position in the nail. | Product: Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 300 mm, Item Number: 814409300
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20180919
The set screw is not able to advance or reverse from the original position in the nail. | Product: Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 380 mm, Item Number: 814509380
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20180919
The set screw is not able to advance or reverse from the original position in the nail. | Product: Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 280 mm, Item Number: 814613280
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20180919
The set screw is not able to advance or reverse from the original position in the nail. | Product: Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 360 mm, Item Number: 814515360
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20180919
The set screw is not able to advance or reverse from the original position in the nail. | Product: Affixus¿ Hip Fracture Nail 125¿ 9 mm x 180 mm, Item Number: 814309180
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20180919
The set screw is not able to advance or reverse from the original position in the nail. | Product: Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 360 mm, Item Number: 814409360
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20180919
The set screw is not able to advance or reverse from the original position in the nail. | Product: Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 260 mm, Item Number: 814413260
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20180919
The set screw is not able to advance or reverse from the original position in the nail. | Product: Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 460 mm, Item Number: 814611460
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180919
The set screw is not able to advance or reverse from the original position in the nail. | Product: Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 420 mm, Item Number: 814413420
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180912
A size 22mm threaded peg was found in the package of a 10mm unit. | Product: Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabiliz
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180711
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potent | Product: Zimmer¿ M/L Taper Hip Prosthesis With ...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180627
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of compl | Product: G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 ...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180627
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of compl | Product: G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 NL...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180627
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of compl | Product: 3.2MM X 560MM COCR THD TIP; 14-441053 ...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180627
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of compl | Product: BALL TIP GUIDE WIRE 3.2MMX55CM; 469055...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180502
Potential failure of sterile packaging seal. | Product: M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter, 70 cm Length; Item Nu
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180404
The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review pro | Product: AIM Tibial Nails intramedullary fixati...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180404
Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical | Product: ACE Trochanteric Nail System STER TRO...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180404
Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper h | Product: Zimmer M/L Taper Hip Prosthesis, 7711 ...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180404
Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle. | Product: Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180321
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from t | Product: CPT 12/14 COCR SIZE 0 STD prosthes...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180321
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from t | Product: VERSYS 6 INCH BEADED FC 13X160MM LM BO...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180321
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from t | Product: LPS PRECOAT FEM SIZE D-RT LPS PRECOAT...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180321
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from t | Product: CR OPTION FEM COMP SIZE C/L CR OPTION...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180321
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from t | Product: LPS-FLEX OPTION FEMORAL C-L LPS-FLEX ...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180228
Robot arm being sent to the wrong position | Product: ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180221
The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners. | Product: G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180207
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an i | Product: Affixus Hip Fracture Nail, 125 DEG 11M...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180207
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an i | Product: Affixus Hip Fracture Nail, LH 125 DEG ...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180207
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an i | Product: Affixus Hip Fracture Nail, RH 130 DEG ...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180207
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an i | Product: Affixus Hip Fracture Nail, RH 125 DEG ...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180207
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an i | Product: Affixus Hip Fracture Nail, LH 130 DEG ...
View Source
FDA Recall: Zimmer Biomet, Inc. — Class II
20180207
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an i | Product: Affixus Hip Fracture Nail, LH 130 DEG ...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180110
Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified bu | Product: RED SEXP DSTL FEM 19CM RT ASSY, model ...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20180110
Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified bu | Product: CER OPTION TYPE 1 TPR SLEVE -6, model ...
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FDA Device Recall: Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 C
2018-12-26
Class II — Correction to update the surgical technique for the Compress System. To make users aware of the changes that were made only to the selection criteria section on page 42 regarding which arra...
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FDA Device Recall: Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
2018-12-19
Class II — Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that...
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FDA Device Recall: Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 cm L
2018-12-12
Class II — Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
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FDA Device Recall: Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm Dia
2018-12-12
Class II — Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
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FDA Device Recall: Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter
2018-12-12
Class II — Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted
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FDA Device Recall: Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Numb
2018-12-12
Class II — Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
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FDA Device Recall: Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 cm L
2018-12-12
Class II — Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
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FDA Device Recall: Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 100 cm Leng
2018-12-12
Class II — Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
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FDA Device Recall: Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 70 cm Lengt
2018-12-12
Class II — Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
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FDA Device Recall: Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diamete
2018-12-12
Class II — Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
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FDA Device Recall: Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip,
2018-12-12
Class II — Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
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FDA Device Recall: Zimmer Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length Item Number
2018-12-12
Class II — Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
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FDA Device Recall: Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
2018-11-28
Class II — Label on the outer carton or the patient labels does not match label on the inner sterile packaging
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FDA Device Recall: Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108
2018-11-28
Class II — Label on the outer carton or the patient labels does not match label on the inner sterile packaging
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FDA Device Recall: Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixu
2018-11-21
Class II — The set screw is not able to advance or reverse from the original position in the nail.
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FDA Device Recall: Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixu
2018-11-21
Class II — The set screw is not able to advance or reverse from the original position in the nail.
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FDA Device Recall: Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 The A
2018-11-21
Class II — The set screw is not able to advance or reverse from the original position in the nail.
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FDA Device Recall: Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The Af
2018-11-21
Class II — The set screw is not able to advance or reverse from the original position in the nail.
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FDA Device Recall: Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The A
2018-11-21
Class II — The set screw is not able to advance or reverse from the original position in the nail.
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FDA Device Recall: Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Affixu
2018-11-21
Class II — The set screw is not able to advance or reverse from the original position in the nail.
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FDA Device Recall: StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use c
2018-11-14
Class II — There is a potential for comingling of the 43MM and 51 MM molds
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FDA Device Recall: Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack
2018-11-14
Class II — Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
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FDA Device Recall: Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Ref Numb
2018-11-14
Class II — Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
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FDA Device Recall: Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, 12 Pack
2018-11-14
Class II — Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
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FDA Device Recall: EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bo
2018-11-07
Class I — Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
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FDA Device Recall: SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini
2018-11-07
Class I — Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
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FDA Device Recall: Affixus Hip Fracture Nail Right 130 11 mm x 340 mm, Item Number 814511340 Pro
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
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FDA Device Recall: Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 814313400 Produ
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
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FDA Device Recall: Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number 814413260 Prod
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
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FDA Device Recall: Affixus Hip Fracture Nail Right 125 11 mm x 440 mm, Item Number 814311440 Pro
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
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FDA Device Recall: Affixus Hip Fracture Nail Right 125 11 mm x 460 mm, Item Number 814311460 Pro
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
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FDA Device Recall: Affixus Hip Fracture Nail Right 125 13 mm x 180 mm, Item Number 814313180 Pro
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
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FDA Device Recall: Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 814611360 Prod
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
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FDA Device Recall: Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number 814409440 Produ
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
View Source
FDA Device Recall: Affixus Hip Fracture Nail Left 125 11 mm x 360 mm, Item Number 814411360 Prod
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
View Source
FDA Device Recall: Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number 814309320 Prod
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
View Source
FDA Device Recall: Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number 814309360 Prod
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
View Source
FDA Device Recall: Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number 814311460 Prod
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
View Source
FDA Device Recall: Affixus Hip Fracture Nail 130 11 mm x 180 mm, Item Number 814511180 Product U
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
View Source
FDA Device Recall: Affixus Hip Fracture Nail Right 130 13 mm x 360 mm, Item Number 814513360 Pro
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
View Source
FDA Device Recall: Affixus Hip Fracture Nail Left 125 9 mm x 460 mm, Item Number 814409460 Produ
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
View Source
FDA Device Recall: Affixus Hip Fracture Nail Right 125 9 mm x 260 mm, Item Number 814309260 Prod
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
View Source
FDA Device Recall: Affixus Hip Fracture Nail Right 130 11 mm x 320 mm, Item Number 814511320 Pro
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
View Source
FDA Device Recall: Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 Prod
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
View Source
FDA Device Recall: Affixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number 814509320 Prod
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
View Source
FDA Device Recall: Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product U
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
View Source
FDA Device Recall: Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number 814311380 Pro
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
View Source
FDA Device Recall: Affixus Hip Fracture Nail Right 125 11 mm x 360 mm, Item Number 814311360 Pro
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
View Source
FDA Device Recall: Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number 814311340 Pro
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
View Source
FDA Device Recall: Affixus Hip Fracture Nail Right 125 9 mm x 380 mm, Item Number 814309380 Prod
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
View Source
FDA Device Recall: Affixus Hip Fracture Nail Left 125 11 mm x 320 mm, Item Number 814411320 Produc
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
View Source
FDA Device Recall: Affixus Hip Fracture Nail Left 125 13 mm x 340 mm, Item Number 814413340 Prod
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
View Source
FDA Device Recall: Affixus Hip Fracture Nail Right 125 13 mm x 440 mm, Item Number 814313440 P
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
View Source
FDA Device Recall: Affixus Hip Fracture Nail Left 130 11 mm x 400 mm, Item Number 814611400 Prod
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
View Source
FDA Device Recall: Affixus Hip Fracture Nail 125 11mm x 180mm, Item Number 814311180 Product Usage
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
View Source
FDA Device Recall: Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number 814511400 Pro
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
View Source
FDA Device Recall: Affixus Hip Fracture Nail Right 125 13 mm x 280 mm, Item Number 814313280 Pro
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
View Source
FDA Device Recall: Affixus Hip Fracture Nail Left 130 11 mm x 380 mm, Item Number 814611380 Pr
2018-10-24
Class II — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
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FDA Device Recall: Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Model
2018-10-03
Class II — The implant only has one bolt in the sterile package but it should have had two.
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FDA Device Recall: Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Mode
2018-10-03
Class II — The implant only has one bolt in the sterile package but it should have had two.
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FDA Device Recall: Gentle Thread PLGA Full Thread Interference Screw, 10x30mm, Item Number 905629
2018-09-26
Class II — The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.
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FDA Device Recall: Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612
2018-09-26
Class II — The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.
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FDA Device Recall: Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 440 mm, Item Number: 814309440
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 460 mm, Item Number: 814309460
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 460 mm, Item Number: 814513460
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 360 mm, Item Number: 814411360
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 280 mm, Item Number: 814511280
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 360 mm, Item Number: 814611360
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 400 mm, Item Number: 814515400
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 400 mm, Item Number: 814611400
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 360 mm, Item Number: 814509360
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 300 mm, Item Number: 814409300
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 380 mm, Item Number: 814509380
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 280 mm, Item Number: 814613280
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 360 mm, Item Number: 814515360
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail 125¿ 9 mm x 180 mm, Item Number: 814309180
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 360 mm, Item Number: 814409360
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 260 mm, Item Number: 814413260
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 460 mm, Item Number: 814611460
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 420 mm, Item Number: 814413420
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 180 mm, Item Number: 814313180
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail 125¿ 11 mm x 180 mm, Item Number: 814311180
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 300 mm, Item Number: 814311300
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 340 mm, Item Number: 814613340
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 300 mm, Item Number: 814313300
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 420 mm, Item Number: 814613420
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 400 mm, Item Number: 814513400
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 320 mm, Item Number: 814309320
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 400 mm, Item Number: 814409400
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 340 mm, Item Number: 814313340
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 300 mm, Item Number: 814613300
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 320 mm, Item Number: 814413320
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 340 mm, Item Number: 814513340
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 460 mm, Item Number: 814411460
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 360 mm, Item Number: 814609360
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 440 mm, Item Number: 814613440
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 400 mm, Item Number: 814613400
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 280 mm, Item Number: 814513280
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 380 mm, Item Number: 814613380
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 420 mm, Item Number: 814611420
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 360 mm, Item Number: 814413360
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 380 mm, Item Number: 814411380
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 320 mm, Item Number: 814411320
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 320 mm, Item Number: 814609320
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 320 mm, Item Number: 814313320
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 380 mm, Item Number: 814511380
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 360 mm, Item Number: 814613360
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 460 mm, Item Number: 814311460
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 280 mm, Item Number: 814611280
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 340 mm, Item Number: 814413340
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 360 mm, Item Number: 814313360
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 260 mm, Item Number: 814509260
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 380 mm, Item Number: 814313380
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 380 mm, Item Number: 814513380
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 460 mm, Item Number: 814313460
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 280 mm, Item Number: 814311280
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 440 mm, Item Number: 814513440
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 420 mm, Item Number: 814509420
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 320 mm, Item Number: 814311320
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 260 mm, Item Number: 814313260
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 320 mm, Item Number: 814611320
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail 130¿ 11 mm x 180 mm, Item Number: 814511180
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 440 mm, Item Number: 814611440
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 400 mm, Item Number: 814511400
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 440 mm, Item Number: 814411440
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 380 mm, Item Number: 814409380
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 420 mm,Item Number: 814313420
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 320 mm, Item Number: 814509320
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 380 mm, Item Number: 814413380
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 420 mm, Item Number: 814511420
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 460 mm, Item Number: 814613460
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 260 mm, Item Number: 814609260
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 420 mm, Item Number: 814411420
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 300 mm, Item Number: 814413300
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 280 mm, Item Number: 814609280
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 280 mm, Item Number: 814413280
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 420 mm, Item Number: 814311420
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 320 mm, Item Number: 814613320
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 280 mm, Item Number: 814409280
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 420 mm, Item Number: 814609420
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 340 mm, Item Number: 814509340
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 440 mm, Item Number: 814311440
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 260 mm, Item Number: 814511260
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 340 mm, Item Number: 814611340
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 440 mm, Item Number: 814509440
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 400 mm, Item Number: 814311400
2018-09-19
Class II — The set screw is not able to advance or reverse from the original position in the nail.
View Source
FDA Device Recall: Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic devi
2018-09-12
Class II — A size 22mm threaded peg was found in the package of a 10mm unit.
View Source
FDA Device Recall: Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-3
2018-08-29
Class II — The PPK System Spacer Block Alignment Tower mating feature that mates with the spacer block was undersized, which could potentially lead to mating issues between the devices. This could cau...
View Source
FDA Device Recall: ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthe
2018-08-22
Class II — Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement co...
View Source
FDA Device Recall: ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item nu
2018-08-22
Class II — Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement co...
View Source
FDA Device Recall: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 13.
2018-07-11
Class II — M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed wi...
View Source
FDA Device Recall: Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 6; 0
2018-07-11
Class II — M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed wi...
View Source
FDA Device Recall: Zimmer¿ M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset; 00-7711
2018-07-11
Class II — M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed wi...
View Source
FDA Device Recall: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 16.
2018-07-11
Class II — M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed wi...
View Source
FDA Device Recall: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 20;
2018-07-11
Class II — M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed wi...
View Source
FDA Device Recall: Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 5; 0
2018-07-11
Class II — M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed wi...
View Source
FDA Device Recall: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 12.
2018-07-11
Class II — M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed wi...
View Source
FDA Device Recall: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 15;
2018-07-11
Class II — M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed wi...
View Source
FDA Device Recall: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 7.5
2018-07-11
Class II — M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed wi...
View Source
FDA Device Recall: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 17.
2018-07-11
Class II — M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed wi...
View Source
FDA Device Recall: Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-1
2018-07-04
Class II — Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extensio...
View Source
FDA Device Recall: G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 Intended to be used as a guide pin for in
2018-06-27
Class II — The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guid...
View Source
FDA Device Recall: G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 NL DRIVING GUIDE 4.4MM X 80CM; 467220 In
2018-06-27
Class II — The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guid...
View Source
FDA Device Recall: 3.2MM X 560MM COCR THD TIP; 14-441053 Intended to be used as a guide pin for
2018-06-27
Class II — The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guid...
View Source
FDA Device Recall: BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin fo
2018-06-27
Class II — The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guid...
View Source
FDA Device Recall: RECON DRILL 6MM X 439MM; 14-443023 Intended to be used as a guide pin for in
2018-06-27
Class II — The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guid...
View Source
FDA Device Recall: GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide pin
2018-06-27
Class II — The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guid...
View Source
FDA Device Recall: DRILL PT GUIDE WIRE 2MM X 60CM; 469320 Intended to be used as a guide pin fo
2018-06-27
Class II — The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guid...
View Source
FDA Device Recall: BEAD TIP GD WIRE 3.0MM X 60CM; 29402 Intended to be used as a guide pin for
2018-06-27
Class II — The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guid...
View Source
FDA Device Recall: DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin fo
2018-06-27
Class II — The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guid...
View Source
FDA Device Recall: Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size
2018-06-20
Class II — One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial ...
View Source
FDA Device Recall: Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For
2018-05-23
Class II — There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetra...
View Source
FDA Device Recall: Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use
2018-05-23
Class II — There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetra...
View Source
FDA Device Recall: Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For
2018-05-23
Class II — There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetra...
View Source
FDA Device Recall: Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For use
2018-05-23
Class II — There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetra...
View Source
FDA Device Recall: Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachme
2018-05-16
Class II — Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
View Source
FDA Device Recall: Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/pol
2018-05-09
Class II — Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.
View Source
FDA Device Recall: M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter, 7
2018-05-02
Class II — Potential failure of sterile packaging seal.
View Source
FDA Device Recall: Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length; Item Number: 47-2255-0
2018-05-02
Class II — Potential failure of sterile packaging seal.
View Source
FDA Device Recall: ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100
2018-05-02
Class II — Potential failure of sterile packaging seal.
View Source
FDA Device Recall: Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Dia
2018-05-02
Class II — Potential failure of sterile packaging seal.
View Source
FDA Device Recall: Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 100 cm Length;
2018-05-02
Class II — Potential failure of sterile packaging seal.
View Source
FDA Device Recall: ZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter, 100 cm Length; I
2018-05-02
Class II — Potential failure of sterile packaging seal.
View Source
FDA Device Recall: Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-22
2018-05-02
Class II — Potential failure of sterile packaging seal.
View Source
FDA Device Recall: Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-
2018-04-25
Class II — There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning p...
View Source
FDA Device Recall: A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number:
2018-04-11
Class II — The drill guides were manufactured with the incorrect color anodization.
View Source
FDA Device Recall: AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508
2018-04-04
Class II — The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.
View Source
FDA Device Recall: ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC NAIL 125 DEG
2018-04-04
Class II — Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to ...
View Source
FDA Device Recall: Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plas
2018-04-04
Class II — Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant.
View Source
FDA Device Recall: Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5
2018-04-04
Class II — Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle.
View Source
FDA Device Recall: ACE Trochanteric Nail System STER TROC LAG SCR 70 MM The Trochanteric Nail S
2018-04-04
Class II — Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to ...
View Source
FDA Device Recall: ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130
2018-04-04
Class II — Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to ...
View Source
FDA Device Recall: ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAIL 3
2018-04-04
Class II — Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to ...
View Source
FDA Device Recall: Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plas
2018-04-04
Class II — Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant.
View Source
FDA Device Recall: ACE Trochanteric Nail System STER TROC NAIL 180X13X140 STER TROC NAIL 125 DEG
2018-04-04
Class II — Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to ...
View Source
FDA Device Recall: ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST 13X
2018-04-04
Class II — Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to ...
View Source
FDA Device Recall: AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255
2018-04-04
Class II — The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.
View Source
FDA Device Recall: ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM STE
2018-04-04
Class II — Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to ...
View Source
FDA Device Recall: Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8
2018-04-04
Class II — One lot of humeral stem implants do not include the humeral bushing components.
View Source
FDA Device Recall: ACE Trochanteric Nail System STER TROC END CAP STER TROC END CAP 5MM STER TRO
2018-04-04
Class II — Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to ...
View Source
FDA Device Recall: ACE Trochanteric Nail System STER TROC NAIL 125 DEG X 9MM STER TROC NAIL 130 D
2018-04-04
Class II — Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to ...
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FDA Device Recall: CPT 12/14 COCR SIZE 0 STD prosthesis, hip, semi-constrained, metal/polymer,
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis, Hip,
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-RT
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZ
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORA
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D-L
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthrop
2018-03-21
Class II — The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur.
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FDA Device Recall: LPS-FLEX GSF OPT SZ C-L¿ LPS-FLEX GSF OPT SZ C-R¿ LPS-FLEX GSF OPT SZ D-L¿ LP
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: 36MM COCR MODULAR HD -6MM
2018-03-21
Class II — One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functi...
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FDA Device Recall: BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicated i
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM COMP
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEM
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: VERSYS 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM STR STD BODY/NECK
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK Prosthesis, Hip, Semi-Cons
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: VERSYS 7.5 IN BEADED FC +10 CALCAR 13.5X180MM STR +10 CALCAR 15.5X180MM STR
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: CR-FLX POR HATCP FEM C-L MINUS CR-FLX POR HATCP FEM C-R MINUS CR-FLX POR HATCP
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: VERSYS 6 INCH BEADED FC 12X160MM LM BODY EXT NECK VERSYS BEADED FULLCOAT REVI
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: LCCK FEM IMPLANT SZ C-L LCCK FEM IMPLANT SZ C-R LCCK FEM IMPLANT SZ D-R LCCK
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: CR-FLEX OPT FEM C-L CR-FLEX OPT FEM C-R CR-FLEX OPT FEM D-L CR-FLEX OPT FEM D
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: VERSYS 10 INCH BEADED FC REV 13.5X250MM BWD LT and RT VERSYS BEADED FULLCOAT
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR FE
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: CR-FLEX GSF PCT SZ C-R MINUS¿ CR-FLEX GSF PCT SZ D-L MINUS¿ CR-FLEX GSF PCT SZ
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: fastener, fixation, nondegradable, soft tissue
2018-03-21
Class II — It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.
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FDA Device Recall: CR-FLEX POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX POR FEM G-L This devi
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL¿ Osteoarthritis
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: CPT 12/14 COCR REVISION SIZE 2 180MM prosthesis, hip, semi-constrained, meta
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision
2018-03-21
Class II — Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot...
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FDA Device Recall: CR-FLEX PCT FEM C-R MINUS CR-FLEX PCT FEM D-L MINUS CR-FLEX PCT FEM D-R MINUS
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: LPS POROUS FEM IMPLANT SZ G-L LPS PRECOAT FEM IMPLANT SZ G-L This device is
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: CPT 12/14 COCR SIZE 2 EXT prosthesis, hip, semi-constrained, metal/polymer,
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: LPS FEM IMPLANT SZ H-R This device is indicated for patients with severe knee
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: LPS OPTION FEMORAL C-L LPS OPTION FEMORAL C-R LPS OPTION FEMORAL D-L LPS OPTI
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: VERSYS 6 INCH BEADED FC 14X160MM STD BODY EXT & STD NECK Prosthesis, Hip, Sem
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: CR POR FEM HATCP SIZE E/L SIZE F/L Knee Prosthesis
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: 6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868
2018-03-21
Class II — One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated screws.
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FDA Device Recall: VERSYS 7.5 INCH BEADED FC REV 13.5X190MM STRAIGHT Prosthesis, Hip, Semi-Const
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provid
2018-03-21
Class II — Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
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FDA Device Recall: NEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT This device is indicated for patien
2018-03-21
Class II — The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is ...
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FDA Device Recall: Sirus Drill 13mm diameter trauma instrument used for preparation of bone in Trau
2018-03-14
Class II — The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the standard cleaning instructions potentially resulting in infection and subsequent complication...
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FDA Device Recall: Flexible Shaft hip and anatomical shoulder instrument used for preparation of bo
2018-03-14
Class II — The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the standard cleaning instructions potentially resulting in infection and subsequent complication...
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FDA Device Recall: 14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument
2018-03-07
Class II — Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.
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FDA Device Recall: 979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.
2018-03-07
Class II — Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.
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FDA Device Recall: Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (I
2018-03-07
Class II — The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.
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FDA Device Recall: ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Inte
2018-02-28
Class II — Robot arm being sent to the wrong position
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FDA Device Recall: Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item
2018-02-28
Class II — Knee implant components (tibial bearings) are labeled with the incorrect size.
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FDA Device Recall: ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. In
2018-02-28
Class II — Robot arm being sent to the wrong position
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FDA Device Recall: G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthrop
2018-02-21
Class II — The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners.
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FDA Device Recall: AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802.
2018-02-21
Class II — The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
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FDA Device Recall: Persona Partial Knee System Product Usage: The Persona Partial Knee System i
2018-02-21
Class II — Potential for the Persona Partial Knee Impactor Pad to fracture.
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FDA Device Recall: M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm L
2018-02-14
Class II — The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging...
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FDA Device Recall: M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter 70
2018-02-14
Class II — The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging...
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FDA Device Recall: Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255-00
2018-02-14
Class II — The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging...
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FDA Device Recall: Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length,
2018-02-14
Class II — The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging...
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FDA Device Recall: Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length,
2018-02-14
Class II — The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging...
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FDA Device Recall: DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE
2018-02-14
Class II — A raw material anomaly was discovered in four lots of raw material and has the potential to be on or below the surface of the device components which can increase the risk of instrument fra...
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FDA Device Recall: Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
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FDA Device Recall: Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
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FDA Device Recall: Affixus Hip Fracture Nail, RH 130 DEG 11MM X 440MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
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FDA Device Recall: Affixus Hip Fracture Nail, RH 125 DEG 11MM X 440MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
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FDA Device Recall: Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
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FDA Device Recall: Affixus Hip Fracture Nail, LH 130 DEG 11MM X 400MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
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FDA Device Recall: Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
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FDA Device Recall: Affixus Hip Fracture Nail, LH 130 DEG 9MM X 400MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
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FDA Device Recall: Affixus Hip Fracture Nail, RH 130 DEG 9MM X 340MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
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FDA Device Recall: Affixus Hip Fracture Nail, RH 130 DEG 9MM X 320MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
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FDA Device Recall: Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
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FDA Device Recall: Affixus Hip Fracture Nail, RH 125 DEG 9MM X 460MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
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FDA Device Recall: Affixus Hip Fracture Nail, RH 130 DEG 13MM X 440MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
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FDA Device Recall: Affixus Hip Fracture Nail, RH 130 DEG 11MM X 360MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
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FDA Device Recall: Affixus Hip Fracture Nail, LH 125 DEG 9MM X 380MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
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FDA Device Recall: Affixus Hip Fracture Nail, LH 125 DEG 9MM X 440MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
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FDA Device Recall: Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
View Source
FDA Device Recall: Affixus Hip Fracture Nail, RH 125 DEG 11MM X 460MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
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FDA Device Recall: Affixus Hip Fracture Nail, RH 130 DEG 9MM X 260MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
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FDA Device Recall: Affixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
View Source
FDA Device Recall: Affixus Hip Fracture Nail, RH 130 DEG 11MM X 380MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
View Source
FDA Device Recall: Affixus Hip Fracture Nail, RH 125 DEG 9MM X 260MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
View Source
FDA Device Recall: Affixus Hip Fracture Nail, LH 130 DEG 13MM X 460MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
View Source
FDA Device Recall: Affixus Hip Fracture Nail, LH 130 DEG 11MM X 460MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
View Source
FDA Device Recall: Affixus Hip Fracture Nail, RH 125 DEG 9MM X 400MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
View Source
FDA Device Recall: Affixus Hip Fracture Nail, LH 125 DEG 11MM X 440MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
View Source
FDA Device Recall: Affixus Hip Fracture Nail, RH 130 DEG 9MM X 380MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
View Source
FDA Device Recall: Affixus Hip Fracture Nail, RH 130 DEG 11MM X 280MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
View Source
FDA Device Recall: Affixus Hip Fracture Nail, LH 125 DEG 9MM X 340MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
View Source
FDA Device Recall: Affixus Hip Fracture Nail, RH 130 DEG 9MM X 440MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
View Source
FDA Device Recall: Affixus Hip Fracture Nail, RH 130 DEG 11MM X 420MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
View Source
FDA Device Recall: Affixus Hip Fracture Nail, RH 125 DEG 13MM X 320MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
View Source
FDA Device Recall: Affixus Hip Fracture Nail, LH 130 DEG 11MM X 280MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
View Source
FDA Device Recall: Affixus Hip Fracture Nail, RH 125 DEG 9MM X 440MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
View Source
FDA Device Recall: Affixus Hip Fracture Nail, RH 130 DEG 9MM X 360MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
View Source
FDA Device Recall: Affixus Hip Fracture Nail, LH 125 DEG 11MM X 320MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
View Source
FDA Device Recall: Affixus Hip Fracture Nail, LH 130 DEG 9MM X 320MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
View Source
FDA Device Recall: Affixus Hip Fracture Nail, RH 130 DEG 11MM X 400MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
View Source
FDA Device Recall: Affixus Hip Fracture Nail, RH 130 DEG 13MM X 460MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
View Source
FDA Device Recall: Affixus Hip Fracture Nail, RH 130 DEG 11MM X 260MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
View Source
FDA Device Recall: Affixus Hip Fracture Nail, LH 130 DEG 11MM X 260MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
View Source
FDA Device Recall: Affixus Hip Fracture Nail, 125 DEG 9MM X 180MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
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FDA Device Recall: Affixus Hip Fracture Nail, LH 130 DEG 9MM X 440MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
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FDA Device Recall: Affixus Hip Fracture Nail, LH 130 DEG 9MM X 420MM
2018-02-07
Class II — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the ...
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FDA Device Recall: RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817
2018-01-10
Class II — Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be i...
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FDA Device Recall: CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064
2018-01-10
Class II — Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be i...
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FDA Device Recall: Lateral Troch Plate Full Crimp - 254mm, model # 350838
2018-01-10
Class II — Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be i...
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FDA Device Recall: PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma
2018-01-10
Class II — Device was distributed with the etching missing from the product.
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FDA Device Recall: COMP 12MM HUM FRAC STEM MACRO, model # 11-113562
2018-01-10
Class II — Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be i...
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FDA Device Recall: OSS CEMENTED IM STEM 12X150, model # 150366
2018-01-10
Class II — Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be i...
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FDA Device Recall: RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828
2018-01-10
Class II — Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be i...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20171129
Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended). | Product: ROSA Surgical Device 2.5.8, a computer-co...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20171129
Non-conforming product label. | Product: ROSA BRAIN 3.0.0
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FDA Recall: Zimmer Biomet, Inc. — Class II
20171004
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or be | Product: Drill Bit Quick-Connect Calibrated 3-F...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20171004
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or be | Product: ECT Internal Fracture Fixation Quick-C...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20171004
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or be | Product: Drill Bit Jacobs Chuck 2.0 mm Diameter...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20171004
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or be | Product: Long Drill 1/4 inch (6.4 mm) Diameter ...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20171004
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or be | Product: ECT Internal Fracture Fixation Drill B...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20171004
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or be | Product: ECT Internal Fracture Fixation Quick-C...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20170809
Complaint of the head holder connector locking up mechanically when tightened. | Product: ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument
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FDA Recall: Zimmer Biomet, Inc. — Class II
20170621
Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verificati | Product: FEM IM NAIL 14MMDX30CM LEFT, FEM IM NA...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20170621
Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packag | Product: Por fullct fem st 17x200mm, Sterile,
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FDA Recall: Zimmer Biomet, Inc. — Class II
20170621
Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packag | Product: Segmental fluted stem, 17x190mm str, S...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20170621
Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packag | Product: Fem IM Nail 14mmdx48cm left, Sterile, ...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20170621
Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packag | Product: Fem IM Nail 16mmdx38cm, Sterile, Rod...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20170621
Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packag | Product: Segmental malefemale taper, 220mm, Ste...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20170621
Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packag | Product: Xl por st 24.0x220mm, bowed, Sterile, ...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20170621
Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packag | Product: Segmental fluted stem, 18x190mm str, S...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20170621
Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verificati | Product: VERSA-FXII SC TUBE PLT 90DX16H, 95DX16...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20170426
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. | Product: various polyethylene implants Sports Med Repicci II Tibial Components Pr...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20170426
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. | Product: various polyethylene implants Knees Revision Tibial Tray Systems Oxford Pa...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20170329
Digital templates were created with the incorrect files. | Product: Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative plan
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FDA Recall: Zimmer Biomet, Inc. — Class II
20170208
labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The mislab | Product: Orthopedic Salvage System (OSS) 9cm p...
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FDA Device Recall: ROSA Surgical Device 2.5.8
2017-12-06
Class II — Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.
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FDA Device Recall: ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide
2017-11-29
Class II — Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).
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FDA Device Recall: ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning a
2017-11-29
Class II — Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller.
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FDA Device Recall: ROSA Surgical Device 2.5.8 It is intended to be used in the operating room
2017-11-29
Class II — Software corrections reactivating the cooperative endoscopy mode.
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FDA Device Recall: ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled elect
2017-11-22
Class II — Observed instability of the device.
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FDA Device Recall: ROSA Surgical Device 2.5.8. It is intended to be used in the operating room
2017-11-22
Class II — An undetected shift between the information displayed in the navigation software and the actual patient anatomy
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FDA Device Recall: Drill Bit Quick-Connect Calibrated 3-Fluted 2.5 mm Diameter 230 mm Length, Item
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 10 cm Length,
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: Drill Bit Jacobs Chuck 2.0 mm Diameter 85 mm Length, Item Number/EDI 00480508520
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: Long Drill 1/4 inch (6.4 mm) Diameter 8 inch (20.3 cm) Length, Item Number/EDI 0
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: ECT Internal Fracture Fixation Drill Bits 2.0 mm Diameter (.079 Inch) , Item Num
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: ECT Internal Fracture Fixation Quick-Connect Drill 2.7 mm Diameter 10 cm Length,
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: Zimmer Periarticular Locking Plate System Drill Standard 2.0 mm Diameter, Item N
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: Drill Bit Quick-Connect 1.1 mm Diameter 60 mm Length, Item Number/EDI 004806060
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: ECT Internal Fracture Fixation Drill Bits 2.7 mm Diameter (.106 Inch), Item Numb
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: ECT Internal Fracture Fixation Quick-Connect Drill, 1.5 mm Diameter, 85mm Length
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: ECT Internal Fracture Fixation Drill Bits 3.5 mm Diameter (.138 Inch), Item Numb
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: ECT Internal Fracture Fixation Long Drill, 6.4 mm (1/4 Inch) Diameter 20.3 cm(8
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: M/DN, Intramedullary Fixation Distal Drill Pilot Tip 3.7 mm Diameter Item Number
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: Drill Bit Quick-Connect 3-Fluted 4.5 mm Diameter 195 mm Length, Item Number/EDI
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: ECT Internal Fixation Drill Bits 2.5 mm Diameter (0.98 Inch), Item Number/EDI 00
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: Zimmer Periarticular Locking Plate System, Locking Screw Tap Standard Quick-Conn
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: Drill Bit Jacobs Chuck 1.5 mm Diameter 70 mm Length, Item Number/EDI 0048050701
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: M/DN Intramedullary Fixation Femoral Drill 3.7 mm Diameter Replaces 2255-08-32,
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 12.5 cm Lengt
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: Drill Bit Quick-Connect 2.0 mm Diameter 100 mm Length, Item Number/EDI 004806100
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: Drill Bit Quick-Connect 3.2 mm Diameter 145 mm Length, Item Number/EDI 004806145
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: Zimmer Periarticular Locking Plate System Drill Standard 2.7 mm Diameter, Item
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: ECT Internal Fracture Fixation Drill 3.5 mm Diameter (.138 Inch), Item Number/ED
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: Zimmer Periarticular Locking Plate System Cannulated Drill Standard Quick-Connec
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: Herbert Cannulated Bone Screw System, Cannulated Main Drill 3.1 mm Diameter, Ite
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: Drill Bit Quick-Connect 4.5 mm Diameter 145 mm Length, Item Number/EDI 004806145
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: ECT Internal Fracture Fixation Drill Bits 1.1 mm Diameter, Item Number/EDI 00231
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: Drill Bit Quick-Connect 2.5 mm Diameter 110 mm Length, Item Number/EDI 004806110
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: M/DN Intramedullary Fixation Distal Drill 3.2 mm Diameter Pilot Tip, Item Number
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 4.5 mm Diameter 19
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: Drill bit Quick-Connect 3-Fluted 2.5 mm Diameter 180 mm Length, Item Number/EDI
2017-10-04
Class II — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the ri...
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FDA Device Recall: ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orient
2017-08-09
Class II — Complaint of the head holder connector locking up mechanically when tightened.
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FDA Device Recall: FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT FEM IM NAIL 13MMDX32C
2017-06-21
Class II — Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
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FDA Device Recall: Por fullct fem st 17x200mm, Sterile,
2017-06-21
Class II — Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
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FDA Device Recall: Segmental fluted stem, 17x190mm str, Sterile, Knee joint femorotibial meta/pol
2017-06-21
Class II — Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
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FDA Device Recall: Fem IM Nail 14mmdx48cm left, Sterile, Rod, fixation, intramedullary and access
2017-06-21
Class II — Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
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FDA Device Recall: Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessories
2017-06-21
Class II — Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
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FDA Device Recall: Segmental malefemale taper, 220mm, Sterile, Knee joint femorotibial meta/polym
2017-06-21
Class II — Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
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FDA Device Recall: Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and access
2017-06-21
Class II — Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
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FDA Device Recall: Segmental fluted stem, 18x190mm str, Sterile, Knee joint femorotibial meta/pol
2017-06-21
Class II — Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
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FDA Device Recall: VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
2017-06-21
Class II — Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
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FDA Device Recall: Segmental fluted stem, 19x190mm str, Sterile, Knee joint femorotibial meta/pol
2017-06-21
Class II — Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
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FDA Device Recall: Segmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/pol
2017-06-21
Class II — Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
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FDA Device Recall: Segmental fluted stem, 15x250mm bwd, Sterile, Knee joint femorotibial meta/pol
2017-06-21
Class II — Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
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FDA Device Recall: Fem IM Nail 15mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories
2017-06-21
Class II — Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
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FDA Device Recall: Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z
2017-06-21
Class II — Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
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FDA Device Recall: VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX
2017-06-21
Class II — Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
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FDA Device Recall: Por fullct fem st 18x200mm, Sterile,
2017-06-21
Class II — Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
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FDA Device Recall: FEM IM NAIL 15MMDX30CM, FEM IM NAIL 16MMDX30CM FEM IM NAIL 14MMDX32CM FEM IM
2017-06-21
Class II — Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
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FDA Device Recall: Xl por st 25.5x220mm, bowed\, bowed, Sterile, Rod, fixation, intramedullary an
2017-06-21
Class II — Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
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FDA Device Recall: Fem IM Nail 16mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories
2017-06-21
Class II — Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
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FDA Device Recall: Fem IM Nail 16mmdx42cm, Sterile, Rod, fixation, intramedullary and accessories
2017-06-21
Class II — Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
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FDA Device Recall: Fem IM Nail 15mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories
2017-06-21
Class II — Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
View Source
FDA Device Recall: Fem IM Nail 15mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories
2017-06-21
Class II — Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
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FDA Device Recall: Por fullct fem st 15x200mm, Sterile, prosthesis, hip, semi-constrained, metal/
2017-06-21
Class II — Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
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FDA Device Recall: TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMDX30
2017-06-21
Class II — Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
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FDA Device Recall: AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is int
2017-06-07
Class II — nail not properly engaging with the targeting jig due to certain undersized specification
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FDA Device Recall: NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthropl
2017-05-24
Class II — Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the pa...
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FDA Device Recall: Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentami
2017-05-17
Class II — Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. A breach in the packaging could lead to loss of sterility of the device.
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FDA Device Recall: Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM R
2017-05-17
Class II — pegs shearing post-operatively
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FDA Device Recall: various polyethylene implants Sports Med Repicci II Tibial Components Prod
2017-04-26
Class II — Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
View Source
FDA Device Recall: various polyethylene implants Knees Revision Tibial Tray Systems Oxford Part
2017-04-26
Class II — Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
View Source
FDA Device Recall: various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight
2017-04-26
Class II — Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
View Source
FDA Device Recall: various polyethylene implants Hips Active Articulation ArComXL Bearings Acti
2017-04-26
Class II — Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
View Source
FDA Device Recall: various polyethylene implants Extremities, Shoulders and Elbows BioModular Sh
2017-04-26
Class II — Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
View Source
FDA Device Recall: MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and
2017-04-19
Class II — Unapproved change made by the supplier.
View Source
FDA Device Recall: Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. F
2017-03-29
Class II — Digital templates were created with the incorrect files.
View Source
FDA Device Recall: Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item
2017-02-22
Class II — Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to potential alumina inclusions in the raw material batch used to produce the affected products....
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FDA Device Recall: Comprehensive Reverse Shoulder System Humeral Tray Model 115340
2017-02-22
Class I — Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.
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FDA Device Recall: Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained
2017-02-08
Class II — labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The mislabeling could have the potential risks: ...
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FDA Device Recall: Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number:
2017-02-08
Class II — packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left). Risk delay in surgery.
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FDA Device Recall: RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm L
2017-01-25
Class II — Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery.
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FDA Device Recall: Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL B
2017-01-25
Class II — Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery.
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FDA Device Recall: Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Steril
2017-01-18
Class II — Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mislabeling. Zimmer Biomet received product complaints reporting that when the package labeled ...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20161026
Contents of the package do not match the product labeling. Product is labeled: Vanguard Distal Femoral Augment 75 X 5 RL/LM Carton contains: Vanguar | Product: Vanguard Distal Femoral Augment 75 X 5...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20160316
Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5, Extend | Product: M/L Taper Hip Prosthesis (Item: 00-771...
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FDA Recall: Zimmer Biomet, Inc. — Class II
20160302
LDPE bag containing the implant adheres to the highly polished implant surface. | Product: NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen Knee LPS Po
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FDA Recall: Zimmer Biomet, Inc. — Class II
20160302
LDPE bag containing the implant adheres to the highly polished implant surface. | Product: NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, knee, patellofemorotibi
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FDA Recall: Zimmer Biomet, Inc. — Class II
20160302
LDPE bag containing the implant adheres to the highly polished implant surface. | Product: CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GSM NP Fl
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FDA Recall: Zimmer Biomet, Inc. — Class II
20160302
LDPE bag containing the implant adheres to the highly polished implant surface. | Product: CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes
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FDA Recall: Zimmer Biomet, Inc. — Class II
20160302
LDPE bag containing the implant adheres to the highly polished implant surface. | Product: NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, knee, patellofemorotibi
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FDA Recall: Zimmer Biomet, Inc. — Class II
20160302
LDPE bag containing the implant adheres to the highly polished implant surface. | Product: NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, patellofemorotibial, semi-c
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FDA Recall: Zimmer Biomet, Inc. — Class II
20160302
LDPE bag containing the implant adheres to the highly polished implant surface. | Product: VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8 INCH BEADE
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FDA Device Recall: Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
2016-11-02
Class II — Complaints have been reported that the handpiece is inoperable. The investigation found that the complaints were related to the lack of preventative maintenance contrary to what is recommen...
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FDA Device Recall: Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and di
2016-10-26
Class II — Contents of the package do not match the product labeling. Product is labeled: Vanguard Distal Femoral Augment 75 X 5 RL/LM Carton contains: Vanguard Distal Femoral Augment 75 X 5 LL/RM ...
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FDA Device Recall: Phoenix Recon Targeting Arm Guide, Surgical, Instrument for the sleeve and Orth
2016-10-19
Class II — Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into the old revision targeting arm...
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FDA Device Recall: Vanguard 360 Revision Knee System Knee prostheses
2016-10-12
Class II — The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included in the Vanguard 360 Revision Knee System was larger than allowable per the proces...
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FDA Device Recall: Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This produc
2016-09-14
Class II — Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small because the lot was packaged with a ...
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FDA Device Recall: Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instrum
2016-06-15
Class II — Zimmer Inc. is initiating a recall of specific Persona" Trabecular Metal" Tibial Plate Instruments and Modular Brackets, due to incidents of radiolucent lines and loosening in implants.
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FDA Device Recall: M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093
2016-03-16
Class II — Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was inco...
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FDA Device Recall: NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem
2016-03-02
Class II — LDPE bag containing the implant adheres to the highly polished implant surface.
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FDA Device Recall: NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, kne
2016-03-02
Class II — LDPE bag containing the implant adheres to the highly polished implant surface.
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FDA Device Recall: CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Na
2016-03-02
Class II — LDPE bag containing the implant adheres to the highly polished implant surface.
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FDA Device Recall: CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemen
2016-03-02
Class II — LDPE bag containing the implant adheres to the highly polished implant surface.
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FDA Device Recall: NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, kne
2016-03-02
Class II — LDPE bag containing the implant adheres to the highly polished implant surface.
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FDA Device Recall: NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, patello
2016-03-02
Class II — LDPE bag containing the implant adheres to the highly polished implant surface.
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FDA Device Recall: VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1
2016-03-02
Class II — LDPE bag containing the implant adheres to the highly polished implant surface.
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FDA Device Recall: NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous FEM
2016-03-02
Class II — LDPE bag containing the implant adheres to the highly polished implant surface.
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FDA Device Recall: VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, por
2016-03-02
Class II — LDPE bag containing the implant adheres to the highly polished implant surface.
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FDA Device Recall: VERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, por
2016-03-02
Class II — LDPE bag containing the implant adheres to the highly polished implant surface.
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FDA Device Recall: Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads Noni
2016-03-02
Class II — LDPE bag containing the implant adheres to the highly polished implant surface.
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FDA Device Recall: CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemen
2016-03-02
Class II — LDPE bag containing the implant adheres to the highly polished implant surface.
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FDA Device Recall: NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial
2016-03-02
Class II — LDPE bag containing the implant adheres to the highly polished implant surface.
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FDA Device Recall: Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemente
2016-03-02
Class II — LDPE bag containing the implant adheres to the highly polished implant surface.
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FDA Device Recall: VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, por
2016-03-02
Class II — LDPE bag containing the implant adheres to the highly polished implant surface.
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FDA Device Recall: Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; Zim
2016-01-20
Class II — Product on the package label did not match what was inside the package. The label was for part number 00-2359-058-35 (Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58mm L...
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FDA Device Recall: Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11
2016-01-20
Class II — The product on the package label did not match what was inside the package. The label was for part number 00-4936-011-13 lot number 62968956 while the product inside the package was part nu...
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ftc
1 records
FTC Case: Zimmer Holdings, Inc. / Biomet, Inc., In the Matter of
FTC enforcement action — tags: enforcement
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lobbying
1 records
Lobbying Firm: ZIMMER BIOMET, INC.
Registered lobbying firm — Washington, DC — Medical Device Company
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ny_corps
1 records
NY Corp: ZIMMER BIOMET INC.
2025-12-08
DOMESTIC BUSINESS CORPORATION | County: Queens | Jurisdiction: New York
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SEC EDGAR
1 records
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