fda
429 records
FDA Recall: Zimmer, Inc. — Class II
20251231
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk i | Product: Brand Name: Affixus Antegrade Femoral ...
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FDA Recall: Zimmer, Inc. — Class II
20251231
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk i | Product: Brand Name: Affixus Antegrade Femoral ...
View Source
FDA Recall: Zimmer, Inc. — Class II
20251231
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk i | Product: Brand Name: Affixus Antegrade Femoral ...
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FDA Device Recall: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg
2025-12-31
Class II — Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs inclu...
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FDA Device Recall: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg
2025-12-31
Class II — Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs inclu...
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FDA Device Recall: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg
2025-12-31
Class II — Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs inclu...
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FDA Device Recall: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg
2025-12-31
Class II — Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs inclu...
View Source
FDA Device Recall: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg
2025-12-31
Class II — Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs inclu...
View Source
FDA Device Recall: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg
2025-12-31
Class II — Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs inclu...
View Source
FDA Device Recall: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg
2025-12-31
Class II — Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs inclu...
View Source
FDA Device Recall: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg
2025-12-31
Class II — Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs inclu...
View Source
FDA Device Recall: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg
2025-12-31
Class II — Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs inclu...
View Source
FDA Device Recall: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg
2025-12-31
Class II — Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs inclu...
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FDA Device Recall: Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D
2025-11-12
Class II — Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the...
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FDA Device Recall: Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D
2025-11-12
Class II — Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the...
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FDA Device Recall: Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 8028
2025-04-30
Class II — The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-ste...
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FDA Device Recall: Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number
2025-04-30
Class II — The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-ste...
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FDA Device Recall: Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number
2025-04-30
Class II — The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-ste...
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FDA Device Recall: Z1 Femoral Hip System, Product Number 611777612
2025-03-19
Class II — There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.
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FDA Device Recall: NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - H
2025-02-05
Class II — It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the s...
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FDA Recall: Zimmer GmbH — Class II
20240918
Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm | Product: Biolox Option Taper Sleeve, Type 1 Tap...
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FDA Device Recall: Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minim
2024-11-13
Class II — A Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a 0.178" difference in the end of the endoscope slot to the end of the tail piece. This allows the scope to move fu...
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FDA Device Recall: Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total
2024-09-18
Class II — Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck ...
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FDA Device Recall: ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, L
2024-05-08
Class II — Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the scr...
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FDA Device Recall: ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated
2024-05-08
Class II — Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the scr...
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FDA Device Recall: ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, L
2024-05-08
Class II — Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the scr...
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FDA Device Recall: ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated fo
2024-05-08
Class II — Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the scr...
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FDA Device Recall: ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate,
2024-05-08
Class II — Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the scr...
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FDA Device Recall: ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated
2024-05-08
Class II — Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the scr...
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FDA Device Recall: ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated
2024-05-08
Class II — Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the scr...
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FDA Device Recall: ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, L
2024-05-08
Class II — Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the scr...
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FDA Device Recall: ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, R
2024-05-08
Class II — Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the scr...
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FDA Device Recall: ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, R
2024-05-08
Class II — Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the scr...
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FDA Device Recall: ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated f
2024-05-08
Class II — Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the scr...
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FDA Device Recall: ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate,
2024-05-08
Class II — Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the scr...
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FDA Device Recall: ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, R
2024-05-08
Class II — Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the scr...
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FDA Device Recall: ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, L
2024-05-08
Class II — Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the scr...
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FDA Device Recall: NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the
2024-05-01
Class II — Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the subst...
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FDA Recall: Zimmer, Inc. — Class II
20230809
Thread form issue of the locking holes in that the locking screws would not properly mate with the plate. The improperly mated screw may not be readil | Product: Zimmer Periarticular Locking Plate (ZP...
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FDA Device Recall: M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Numb
2023-09-13
Class II — The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.
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FDA Device Recall: Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 1
2023-08-09
Class II — Thread form issue of the locking holes in that the locking screws would not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the sc...
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FDA Device Recall: NexGen Precoat Stemmed Tibial Plate Size 5
2023-07-12
Class II — Device outer packaging was incorrectly labeled.
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FDA Device Recall: Identity Shoulder System Resection Planer 35mm Resection Planer
2023-02-15
Class II — Two planers were found to be unusable during sawbones shoulder training.
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FDA Recall: Zimmer, Inc. — Class II
20221012
The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during tran | Product: G7 Acetabular System, Acetabular Shell...
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FDA Device Recall: NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01
2022-12-21
Class II — Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revis...
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FDA Device Recall: NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01
2022-12-21
Class II — Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revis...
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FDA Device Recall: NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02
2022-12-21
Class II — Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revis...
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FDA Device Recall: NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02
2022-12-21
Class II — Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revis...
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FDA Device Recall: G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52
2022-10-12
Class II — The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinic...
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FDA Recall: Zimmer GmbH — Class II
20210609
Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree | Product: Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 ...
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FDA Device Recall: Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD L
2021-06-09
Class II — Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree
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FDA Device Recall: Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CCD L
2021-06-09
Class II — Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree
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FDA Recall: Zimmer GmbH — Class II
20190529
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | Product: V-TEK", IVP step drill 2.5-3.9x124mm, 16mm ...
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FDA Recall: Zimmer GmbH — Class II
20190529
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | Product: Drill, contra-angle, 1.5x85mm, Item Number ...
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FDA Recall: Zimmer GmbH — Class II
20190529
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | Product: Drill, cannulated, 3x90mm, AO, Item Number ...
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FDA Recall: Zimmer GmbH — Class II
20190529
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | Product: CBS micro, countersink, cannulated, round-s...
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FDA Recall: Zimmer GmbH — Class II
20190529
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | Product: Drill, 15mm stop, 1x83mm, Stryker, Item Num...
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FDA Recall: Zimmer GmbH — Class II
20190529
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | Product: Drill, cannulated, 2.5x95mm, AO, Item Numbe...
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FDA Recall: Zimmer GmbH — Class II
20190529
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | Product: Drill for 3.5mm screw, 2.5x120mm, AO, Item ...
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FDA Recall: Zimmer GmbH — Class II
20190529
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | Product: Drill, cannulated, 2.8x150mm, AO, Item Numb...
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FDA Recall: Zimmer GmbH — Class II
20190529
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | Product: V-TEK", IVP step drill 2.5-3.9x124mm, 16mm ...
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FDA Recall: Zimmer GmbH — Class II
20190529
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | Product: Drill, cannulated, 3x90mm, round shaft, Ite...
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FDA Recall: Zimmer GmbH — Class II
20190529
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | Product: CBS 4.0 countersink, cannulated, 15mm stop,...
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FDA Recall: Zimmer GmbH — Class II
20190529
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | Product: Drill, cannulated, 2.8x120mm, AO, Item Numb...
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FDA Recall: Zimmer GmbH — Class II
20190529
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | Product: Drill, cannulated, 4x120mm, AO, Item Number...
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FDA Recall: Zimmer GmbH — Class II
20190529
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | Product: Drill for 2.7mm screw, 2x120mm, AO, Item Nu...
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FDA Recall: Zimmer GmbH — Class II
20190529
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | Product: Drill, 26mm stop, 1.4x94mm, Stryker, Item N...
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FDA Device Recall: V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, contra-angle, Item Number 50201
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, contra-angle, 1.5x85mm, Item Number ST502015706
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, cannulated, 3x90mm, AO, Item Number ST502015631
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: CBS micro, countersink, cannulated, round-shaft, Item Number 503004341
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, 15mm stop, 1x83mm, Stryker, Item Number 502015114
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, cannulated, 2.5x95mm, AO, Item Number 502015621
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill for 3.5mm screw, 2.5x120mm, AO, Item Number ST502015216
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, cannulated, 2.8x150mm, AO, Item Number 502015629
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, AO, Item Number 502015638
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, cannulated, 3x90mm, round shaft, Item Number 502015630
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: CBS 4.0 countersink, cannulated, 15mm stop, AO, Item Number 503004352
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, cannulated, 2.8x120mm, AO, Item Number ST502015628
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, cannulated, 4x120mm, AO, Item Number ST502015402
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill for 2.7mm screw, 2x120mm, AO, Item Number 502015212
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, 26mm stop, 1.4x94mm, Stryker, Item Number 502015120
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: CBS 7.5 tap, cannulated, AO, Item Number 503002041
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill for 2.7mm screw, 23mm stop, 2x103mm, AO, Item Number ST502015207
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill for 3.5mm screw, 2.5x120mm, AO, Item Number 502015216
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, 26mm stop, 1.4x94mm, stryker, Item Number 502015145
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: V-TEK", Micro-countersink, AO, Item Number 28.66.113
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, cannulated, 2x95mm, round shaft, Item Number 502015619
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: CBS high, countersink, cannulated, round-shaft, Item Number 503004342
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, cannulated, 2.8x120mm, AO, Item Number 502015628
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, 2.5x135mm, AO, Item Number 502015142
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, cannulated, 4x90mm, round shaft, Item Number ST502015640
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: CBS 4.5 countersink, cannulated, 18mm stop, round-shaft, Item Number 503004351
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, 3.2x145mm, AO, Item Number ST502015650
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, cannulated, 2x95mm, AO, Item Number 502015623
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, cannulated, 3.5x90mm, round shaft, Item Number ST502015635
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, cannulated, 2.5x95mm, AO, Item Number ST502015621
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, contra-angle, 1.5x85mm, Item Number 502015706
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, cannulated, 3x90mm, AO, Item Number 502015631
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: CBS micro, countersink, cannulated, AO, Item Number 503004541
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, cannulated, 3.5x90mm, round shaft, Item Number 502015635
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: V-TEK", micro-countersink, round shaft, Item Number 28.66.112
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, cannulated, 2x95mm, round shaft, Item Number ST502015619
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill Sys2.7, 2x103mm, AO, Item Number 502015107
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Osteofresh arthrodesis drill, 2x70mm, center tip, AO, 10mm stop, Item Number 502
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, cannulated, 4x90mm, round shaft, Item Number 502015640
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill Sys 2.7, 2x105mm, stryker, Item Number 502015106
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, 2.5x94mm, Stryker, Item Number 502015136
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: V-TEK", standard-countersink, cannulated, AO, Item Number 28.66.111
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, 19mm stop, 1.9x87mm, AO, Item Number 502015131
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, 2.5x87mm, AO, Item Number 502015137
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, cannulated, 2x95mm, AO, Item Number ST502015623
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Device Recall: Drill, 15mm stop, 1x76mm, AO , Item Number 502015115
2019-05-29
Class II — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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FDA Recall: Zimmer GmbH — Class II
20180502
A potential commingle that could result in the product in the package not matching the product on the outer label. | Product: Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: ...
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FDA Device Recall: Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)008
2018-05-02
Class II — A potential commingle that could result in the product in the package not matching the product on the outer label.
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FDA Device Recall: Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00
2018-05-02
Class II — A potential commingle that could result in the product in the package not matching the product on the outer label.
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FDA Device Recall: Normed Charcot Osteotome Chisel (Various sizes)
2018-04-18
Class II — Product may contain a gap between the handle and metal chisel which can lead to failure to properly disinfect or sterilize between use.
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FDA Device Recall: Normed General Instruments 503004541: Werber Countersink Cannulated for micro C
2017-05-24
Class II — the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage.
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FDA Recall: Zimmer Gmbh — Class II
20160810
Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twis | Product: V-TEK TWIST D 3.5X90MM 30MM Can 12MM R...
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FDA Device Recall: V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd; The twist drill is used to drill holes
2016-08-10
Class II — Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (...
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FDA Device Recall: V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill holes
2016-08-10
Class II — Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (...
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FDA Device Recall: Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS
2016-06-22
Class II — In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which resulted i...
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FDA Recall: Zimmer, Inc. — Class II
20150722
A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Potential for fatigue of implant prior to sufficient fracture healing, | Product: ZNN Antegrade Femoral Nail (ZNN AF). ...
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FDA Recall: Zimmer Gmbh — Class II
20150304
Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inn | Product: CoCr Femoral Head - A modular head com...
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FDA Recall: Zimmer Gmbh — Class II
20150304
Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inn | Product: Metasul Femoral Head - indicated for ...
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FDA Device Recall: Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger
2015-12-30
Class II — The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected.
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FDA Device Recall: Persona EM Distal Rod, orthopedic manual surgical instrument for use with Person
2015-12-16
Class II — Complaints that the ratchet teeth of the tube are not latching onto the rod.
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FDA Device Recall: Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument
2015-10-14
Class II — It was found through review of open Complaints and stock investigations that a single lot of Zimmer Universal Locking System 3.5 mm Stainless Steel Base and Trays has incorrect silk screeni...
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FDA Device Recall: Zimmer Guide Wires for orthopedic procedures.
2015-10-07
Class II — Product labeling of these sterile guide wires (external carton label and patient record label) states a 10-year expiration date. Package testing supports a 5-year expiration date for these ...
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FDA Device Recall: ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
2015-07-22
Class II — A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Potential for fatigue of implant prior to sufficient fracture healing, which may result in need for implant r...
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FDA Device Recall: Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in con
2015-07-08
Class II — Failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity. If the outer tray is compromised in addition to the inner tray a periprosthetic i...
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FDA Device Recall: Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail Sy
2015-06-10
Class II — The entire scope of 4.5mm Cortical Screws listed as compatible with the M/DN system is not compatible with the M/DN system. This has the potential to lead to a situation in which the screw...
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FDA Device Recall: Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joi
2015-05-06
Class II — Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). This ha...
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FDA Device Recall: CoCr Femoral Head - A modular head component is used in conjunction with a femor
2015-03-04
Class II — Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and t...
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FDA Device Recall: Metasul Femoral Head - indicated for total hip arthroplasty for treatment of pa
2015-03-04
Class II — Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and t...
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FDA Device Recall: Metasul Femoral Head - A modular head component is used in conjunction with a fe
2015-03-04
Class II — Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and t...
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FDA Device Recall: CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skelet
2015-03-04
Class II — Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and t...
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FDA Device Recall: Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in con
2015-03-04
Class II — Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and t...
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FDA Device Recall: Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Cat
2015-02-11
Class II — Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of sonic cleaning can break down the ball bearing retention feature (swage) on the shim. To prev...
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FDA Device Recall: Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder t
2015-01-07
Class II — Samples of product from Supplier lot 14D0809 and 14D0808 showed little adhesive transfer between the Tyvek lid and cavity when opened for internal bone cement cure and pairing tests. Visual...
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FDA Recall: Zimmer, Inc. — Class II
20141008
The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm P | Product: Persona The Personalized Knee System 2...
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FDA Recall: Zimmer, Inc. — Class II
20140910
Zimmer received a trend of complaints indicating corrosion of product. | Product: Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number: 6290-00-702.
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FDA Recall: Zimmer, Inc. — Class II
20140910
Zimmer received a trend of complaints indicating corrosion of product. | Product: Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690.
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FDA Recall: Zimmer, Inc. — Class II
20140903
Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification te | Product: Moore & Thompson Hip Stems: FNSTRD HI...
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FDA Recall: Zimmer, Inc. — Class II
20140827
Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | Product: 4.5 mm Malleolar Screw Sterile zimmer
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FDA Recall: Zimmer, Inc. — Class II
20140827
Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall | Product: Persona (TM) The Personalized Knee Sy...
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FDA Recall: Zimmer, Inc. — Class II
20140827
Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | Product: 6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
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FDA Recall: Zimmer, Inc. — Class II
20140820
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of | Product: Vl DBL OFFST WI LRG STPL, RT Nonsteri...
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FDA Recall: Zimmer, Inc. — Class II
20140820
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of | Product: Double Offset Rasp Handle, Right Hand ...
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FDA Recall: Zimmer, Inc. — Class II
20140709
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. | Product: NexGen Complete Knee Solution, MIS Total Knee Procedur...
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FDA Recall: Zimmer, Inc. — Class II
20140709
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. | Product: NexGen Complete Knee Solution, MIS Total Knee Procedur...
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FDA Recall: Zimmer, Inc. — Class II
20140709
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. | Product: NexGen Complete Knee Solution, MIS Total Knee Procedur...
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FDA Recall: Zimmer, Inc. — Class II
20140521
During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex. | Product: Tennis Elbow Support, Neoprene***LATEX FREE...
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FDA Recall: Zimmer, Inc. — Class II
20140521
During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex. | Product: Hinged Knee Support***LATEX FREE" Produ...
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FDA Recall: Zimmer, Inc. — Class II
20140326
A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. T | Product: Natural-Knee¿/Apollo" Knee: M/B PAT S...
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FDA Recall: Zimmer, Inc. — Class II
20140226
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based | Product: 2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 COR...
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FDA Recall: Zimmer, Inc. — Class II
20140226
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based | Product: 1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 COR...
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FDA Recall: Zimmer, Inc. — Class II
20140226
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based | Product: PRESSFIT FEM ST FX 16 X 1
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FDA Recall: Zimmer, Inc. — Class II
20140226
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based | Product: 3.5 X 10 CORT SCREW SELFT 3.5 X 12 CO...
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FDA Recall: Zimmer, Inc. — Class II
20140226
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based | Product: 12/14 COCR FEMORAL HEAD (2, 3 and 4); ...
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FDA Recall: Zimmer, Inc. — Class II
20140226
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based | Product: MOORE HIP PROS LONG FENES, MOORE HIP P...
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FDA Recall: Zimmer, Inc. — Class II
20140226
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based | Product: CPT 12/14 COCR (various sizes)
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FDA Recall: Zimmer, Inc. — Class II
20140226
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based | Product: Bipolar liners and Multipolar cups wit...
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FDA Recall: Zimmer, Inc. — Class II
20140122
The patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on the | Product: Palacos¿ R+G Radioplaque Bone Cement 1...
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FDA Device Recall: Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibia
2014-12-31
Class II — The affected lot was supplied by contract manufacturer and are potentially subject to disassociation of the magnet cover. Zimmer received one complaint indicating the magnet cover of a Pers...
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FDA Device Recall: Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non
2014-12-17
Class II — Possibility of the weld to the quick-connect breaking when force is applied to the handle for pedicle screw removal. A broken weld could lead to the use of an alternate method of screw re...
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FDA Device Recall: Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial
2014-12-03
Class II — To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor...
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FDA Device Recall: Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indi
2014-11-19
Class II — Cleaning process validation failure.
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FDA Device Recall: The Persona Tibial Articular Surface Inserter is a sterilizable instrument inten
2014-10-29
Class II — Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.
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FDA Device Recall: Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qt
2014-10-08
Class II — The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm Persona Hex Driver.
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FDA Device Recall: Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Numbe
2014-09-10
Class II — Zimmer received a trend of complaints indicating corrosion of product.
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FDA Device Recall: Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Numb
2014-09-10
Class II — Zimmer received a trend of complaints indicating corrosion of product.
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FDA Device Recall: PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Le
2014-09-10
Class II — Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure...
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FDA Device Recall: Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Numbe
2014-09-10
Class II — Zimmer received a trend of complaints indicating corrosion of product.
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FDA Device Recall: PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Lef
2014-09-10
Class II — Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure...
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FDA Device Recall: Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FNSTR
2014-09-03
Class II — Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple tes...
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FDA Device Recall: Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS H
2014-09-03
Class II — Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple tes...
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FDA Device Recall: Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT
2014-09-03
Class II — Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple tes...
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FDA Device Recall: Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD 42
2014-09-03
Class II — Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple tes...
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FDA Device Recall: Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG TU
2014-09-03
Class II — Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple tes...
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FDA Device Recall: Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG
2014-09-03
Class II — Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple tes...
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FDA Device Recall: 4.5 mm Malleolar Screw Sterile zimmer
2014-08-27
Class II — Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
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FDA Device Recall: Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional
2014-08-27
Class II — Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actio...
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FDA Device Recall: 6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
2014-08-27
Class II — Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
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FDA Device Recall: 6.5 mm Cancellous Screw 32 mm Thread Length Sterile zimmer
2014-08-27
Class II — Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
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FDA Device Recall: Persona (TM) The Personalized Knee System PS Tibial Articular Surface Provisio
2014-08-27
Class II — Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective acti...
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FDA Device Recall: 6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer
2014-08-27
Class II — Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
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FDA Device Recall: Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile z
2014-08-27
Class II — Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
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FDA Device Recall: 6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
2014-08-27
Class II — Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
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FDA Device Recall: PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-st
2014-08-27
Class II — The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the specific geometry to accommodate the tibial drill and stop guide with proper position/orien...
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FDA Device Recall: PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-st
2014-08-27
Class II — The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the specific geometry to accommodate the tibial drill and stop guide with proper position/orien...
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FDA Device Recall: Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional
2014-08-27
Class II — Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actio...
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FDA Device Recall: Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisi
2014-08-27
Class II — Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actio...
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FDA Device Recall: Vl DBL OFFST WI LRG STPL, RT Nonsterile
2014-08-20
Class II — The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
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FDA Device Recall: Double Offset Rasp Handle, Right Hand Nonsterile
2014-08-20
Class II — The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
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FDA Device Recall: Double Offset Rasp Handle, Left Hand Nonsterile
2014-08-20
Class II — The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
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FDA Device Recall: Double Offset Rasp Handle, Left Hand Nonsterile
2014-08-20
Class II — The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
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FDA Device Recall: Double Offset Rasp Handle, Left Hand Nonsterile
2014-08-20
Class II — The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
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FDA Device Recall: 23.5 Deg Rasp Handle Assy- RIGHT Nonsterile
2014-08-20
Class II — The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
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FDA Device Recall: VI DBL OFFST W/ LRG STPL, LT Nonsterile
2014-08-20
Class II — The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
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FDA Device Recall: Double Offset Rasp Handle, Left Hand Nonsterile
2014-08-20
Class II — The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
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FDA Device Recall: VER2 DBL OFFSET RASP HANDLE, LT Nonsterile
2014-08-20
Class II — The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
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FDA Device Recall: Double Offset Rasp Handle, Right Hand Nonsterile
2014-08-20
Class II — The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
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FDA Device Recall: Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203
2014-08-20
Class II — Zimmer is initiating a voluntary recall of 20 production lots of Moore Hip Prosthesis Long Fenestrated Stems due to packaging design verification test failures. Specifically, 9 of 16 test s...
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FDA Device Recall: Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right)
2014-08-20
Class II — The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
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FDA Device Recall: 23.5 Deg Rasp Handle Assy- LEFT Nonsterile
2014-08-20
Class II — The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
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FDA Device Recall: Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006
2014-07-23
Class II — Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due to a potential crack in the cap of the ou...
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FDA Device Recall: Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS¿,
2014-07-16
Class II — Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.
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FDA Device Recall: NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Componen
2014-07-09
Class II — Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
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FDA Device Recall: NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Componen
2014-07-09
Class II — Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
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FDA Device Recall: NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Componen
2014-07-09
Class II — Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
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FDA Device Recall: NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Componen
2014-07-09
Class II — Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
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FDA Device Recall: NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Componen
2014-07-09
Class II — Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
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FDA Device Recall: NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Componen
2014-07-09
Class II — Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
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FDA Device Recall: NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Componen
2014-07-09
Class II — Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
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FDA Device Recall: VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581
2014-07-02
Class II — During routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-102. Processing of Beaded CoCrMo Alloy Hip Stem, material requirements per ATS #14-04818 and...
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FDA Device Recall: Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides compre
2014-05-21
Class II — During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
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FDA Device Recall: Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral stabi
2014-05-21
Class II — During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
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FDA Device Recall: Cartilage Knee Brace***LATEX FREE" Product Usage: Used in the treatment a
2014-05-21
Class II — During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
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FDA Device Recall: DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment, su
2014-05-21
Class II — During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
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FDA Device Recall: TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60
2014-04-30
Class II — The shell was missing the locking ring.
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FDA Device Recall: Natural-Knee¿/Apollo" Knee: M/B PAT SZ0 NATURAL-KNEE M/B PAT SZ1 NATURAL-KNEE
2014-03-26
Class II — A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prem...
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FDA Device Recall: Natural-Knee¿ II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II CO
2014-03-26
Class II — A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prem...
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FDA Device Recall: Natural-Knee¿ II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM UN
2014-03-26
Class II — A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prem...
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FDA Device Recall: Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO CON
2014-03-26
Class II — A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prem...
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FDA Device Recall: Natural-Knee¿ N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1
2014-03-26
Class II — A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prem...
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FDA Device Recall: MOST Options" System (MOST) HINGED TIB INS SZ 1 16MM HINGED TIB INS SZ 4 6MM M
2014-03-26
Class II — A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prem...
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FDA Device Recall: Natural-Knee¿ Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 SF
2014-03-26
Class II — A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prem...
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FDA Device Recall: Natural-Knee¿ II Unicompartmental Knee System: UNI ALL-POLY TIB SZ 1-7mm UNI A
2014-03-26
Class II — A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prem...
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FDA Device Recall: Natural-Knee¿ II Constrained Knee System NKII CCK TIB INS SZ00/0-L NKII CCK TI
2014-03-26
Class II — A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prem...
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FDA Device Recall: Trabecular Metal" Reverse Shoulder System
2014-03-05
Class II — As a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate, Zimmer updated the related surgical technique and released a video to provide additional instr...
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FDA Device Recall: 00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem
2014-03-05
Class II — This single manufacturing lot has the potential for the bond strength between the Trabecular Metal material and substrate to be below the minimum required specification. Testing found bond...
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FDA Device Recall: 2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELFTA
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: 1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: PRESSFIT FEM ST FX 16 X 1
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: 3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT SCREW SELFT 3.5 X 14 CORT SCREW SELFT
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: 12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M)
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST,
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: CPT 12/14 COCR (various sizes)
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: Bipolar liners and Multipolar cups with the following dimensions in MM (38, 39,
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 00114
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, VER
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item codes
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: 3.5 COMP PLT, 4 HOLE 3.5 COMP PLT, 5 HOLE 3.5 COMP PLT, 6 HOLE
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: DISTAL MEDIAL FEMORAL CON, DISTAL POSTERIOR/LATERAL, DISTAL SMALL VOLAR RADIUS,
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: ZIMTRON 6 DEG 22 HEADS
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: ASIA ONE-PIECE LAG SCREW
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 00
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. S
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: COMPRESSION SCREW (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 IN)
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: 12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X12
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: TRILOGY ACET SHELL 36MM O TRILOGY ACET SHELL 38MM O TRILOGY ACET SHELL 40MM O
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: NEXGEN MIS TIBIA PLATE PR NEXGEN TAPER PLUG NEXGEN PRECOAT PEG TIB PL
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: HGP II ACETABULAR CUP MOD
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: HGP II ACETABULAR CUP BON
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: 6 DEGREE COCR FEM HEAD 36
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900.
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE PL,
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATE
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes star
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG Some items starting wi
2014-02-26
Class II — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that...
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FDA Device Recall: Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g M
2014-01-22
Class II — The patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on the outer carton label.
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FDA Device Recall: NGK Stem Ext 24 x 245mm
2014-01-08
Class II — Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product fro...
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FDA Device Recall: DIST LAT FEM LOCK PLT, RT
2014-01-08
Class II — Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product fro...
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FDA Device Recall: Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip ar
2014-01-08
Class II — Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged...
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FDA Device Recall: CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer
2014-01-08
Class II — Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged...
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FDA Device Recall: FEM COND BUTTRESS PLT, LT
2014-01-08
Class II — Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product fro...
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FDA Device Recall: TIB NAIL
2014-01-08
Class II — Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product fro...
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FDA Recall: Zimmer, Inc. — Class II
20131218
Two complaints were received in which it was reported that the stem would not lock into the tibia. Evaluation of the returned device found that the s | Product: NexGen¿ Complete Knee Solutions Stemme...
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FDA Recall: Zimmer, Inc. — Class II
20131113
Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product pack | Product: Ti-Magna Fx Washer Ti-Versa-FX¿II Fem...
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FDA Recall: Zimmer, Inc. — Class II
20131106
The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. | Product: Natural-Knee¿ Flex Femoral Component. Provides increased flexion c...
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FDA Recall: Zimmer, Inc. — Class II
20131106
The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. | Product: CoCr Head (Not distributed in the United States) Used in total hip...
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FDA Recall: Zimmer, Inc. — Class II
20130904
Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product. | Product: VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSI...
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FDA Recall: Zimmer, Inc. — Class II
20130904
Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product. | Product: Free Lock Femoral Hip Fixation System Compres...
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FDA Recall: Zimmer, Inc. — Class II
20130828
Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standa | Product: 90597003109 Articular Surface CR ART S...
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FDA Recall: Zimmer, Inc. — Class II
20130828
Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standa | Product: 65595201201 Femur ...
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FDA Recall: Zimmer, Inc. — Class II
20130828
Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standa | Product: 00597002009 Articular Surface CR ART S...
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FDA Recall: Zimmer, Inc. — Class II
20130828
Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standa | Product: 00595601201 Femur CR-FLEX OPT FEM B-L ...
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FDA Recall: Zimmer, Inc. — Class II
20130828
Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standa | Product: 90597004109 Articular Surface CR ART S...
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FDA Recall: Zimmer, Inc. — Class II
20130710
This is a recall expansion from the 2010 recall which now includes seven additional lots that were not previously included. Zimmer, Inc. is initiatin | Product: Bigliani/Flatow¿ The Complete Solution...
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FDA Recall: Zimmer, Inc. — Class II
20130410
Possibility that the inner pouch may be compromised. The product is packaged in two pouches - a sterile inner pouch within an external pouch. NexPosur | Product: Zimmer NexPosure, retractor portals of...
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FDA Device Recall: NexGen¿ Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibia
2013-12-18
Class II — Two complaints were received in which it was reported that the stem would not lock into the tibia. Evaluation of the returned device found that the stemmed portion of the tibial plate woul...
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FDA Device Recall: NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thickne
2013-12-18
Class II — This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro components. Th...
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FDA Device Recall: Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total an
2013-12-18
Class II — As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing eleva...
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FDA Device Recall: NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow 9mm Heigh
2013-12-18
Class II — This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro components. Th...
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FDA Device Recall: NexGen Complete Knee Solution CR Articular Surface Provisional-Purple 9mm Heigh
2013-12-18
Class II — This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro components. Th...
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FDA Device Recall: NexGen Complete Knee Solution Porous Patella Drill Guide-29mm dia./10mm thickne
2013-12-18
Class II — This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro components. Th...
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FDA Device Recall: Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ank
2013-12-18
Class II — As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing eleva...
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FDA Device Recall: Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, Rx
2013-11-27
Class II — Zimmer Spine, Inc. is initiating a correction regarding the Trinica ALP Instrument Tray, part 07.01058.001 (all lots). The Ratchet Handles, part 07.00438.001 may not be effectively sterili...
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FDA Device Recall: VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage
2013-11-20
Class II — Based on a review of historic packaging validations, it was determined that a subset of product packaged in one of the clean rooms at a single Zimmer facility required testing to ensure tha...
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FDA Device Recall: Ti-Magna Fx Washer Ti-Versa-FX¿II Femoral Fixation System S/C Plates The c
2013-11-13
Class II — Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single Zimmer facility requir...
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FDA Device Recall: Natural-Knee¿ Flex Femoral Component. Provides increased flexion capability.
2013-11-06
Class II — The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
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FDA Device Recall: CoCr Head (Not distributed in the United States) Used in total hip replacemen
2013-11-06
Class II — The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
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FDA Device Recall: NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United
2013-11-06
Class II — The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
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FDA Device Recall: Metasul¿ Head. Intended for use either with or without bone cement in total h
2013-11-06
Class II — The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
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FDA Device Recall: Zimmer¿ Unicompartmental Knee Femoral Component. Indicated for patients with
2013-11-06
Class II — The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
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FDA Device Recall: Multipolar¿ Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in f
2013-11-06
Class II — The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
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FDA Device Recall: NexGen¿ Femoral Component (CR-FLEX GSF POR FEM, C-L; CR-FLEX GSF POR FEM, C-R; C
2013-11-06
Class II — The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
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FDA Device Recall: Gender Solutions" Patello-Femoral Component
2013-11-06
Class II — The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
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FDA Device Recall: NexGen¿ Femoral Component (CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOAT S
2013-11-06
Class II — The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
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FDA Device Recall: VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short -
2013-09-04
Class II — Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.
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FDA Device Recall: Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (5
2013-09-04
Class II — Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.
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FDA Device Recall: 90597003109 Articular Surface CR ART SURF 34/STR YEL 09MM, Rx, Sterile; 90597
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 65595201201 Femur CR-FLEX POR HATCP FEM B-L Rx, Sterile
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00597002009 Articular Surface CR ART SURF 12/PURPLE 9, Rx, Sterile; 005970020
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00595601201 Femur CR-FLEX OPT FEM B-L Rx Sterile; 00595601202 Femur CR-FLEX
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx, Sterile; 905
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM, Rx, Sterile; 905970
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00597001303 Femur CR PRC FEM COMP SIZE CML Rx, Sterile; 00597001304 Femur C
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00597206126 Patella ALL POLY PAT COMP MICRO 26DIA, Rx, Sterile; 00597206129 P
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00597103110 Provisional CR ART SURF PROV 34/STR YEL 10, Rx, Sterile; 0059710
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00595204110 Articular Surface XLPE CR ART SURF 5-6/STRGRN 10, Rx, Sterile; 00
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00595202010 Articular Surface XLPE CR ART SURF 1,2/PUR 10, Rx, Sterile; 00595
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00597003109 Articular Surface CR ART SURF 34/STRIPE YEL 9, Rx, Sterile; 00597
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00597201101 Femur CR POROUS FEM COMP SIZE AML Rx, Sterile; 00597201102 Femur
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00597001333 Femur CR PRC SURF HDN FEM CO-NID CML Rx, Sterile; 00597001334 Fe
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00595501201 Provisional CR-FLEX FEM PROV SZ B-L, Rx, Sterile; 00595501202 Pr
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00597201333 Femur CR POR SURF HDN FEM CO-NID CML, Rx, Sterile; 00597201334 Fe
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00597104110 Provisional CR ART SURF PROV 56/STR GRN 10, Rx, Sterile; 0059710
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00597504110 Provisional AC ART SURF PROV 56/STR GRN 10, Rx, Sterile; 0059750
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00595203110 Articular Surface XLPE CR ART SURF 3,4/SYEL 10, Rx, Sterile; 0059
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00597203109 Articular Surface CR ART SURF 34/STRIPE YEL 09, Rx, Sterile; 0059
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00597204109 Articular Surface CR ART SURF 56/STRIPE GRN 9, Rx, Sterile; 00597
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00597001101 Femur CR PRECOAT FEM COMP SIZE AM
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00597101101 Provisional CR PROV FRM COMP SIZE AML, Rx, Sterile; 00597101102
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 90595202017 Articular Surface XLPE CR ART SURF AE12/PUR 17, Rx, Sterile; 9059
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem l
2013-08-28
Class II — Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single Zimmer facility requir...
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FDA Device Recall: 65597201101 Femur CR POR FEM HATCP SIZE AML Rx, Sterile; 65597201102 Femur
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 005
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00597201131 Femur CR POR SURF HDN FEM CO-NID AML Rx, Sterile; 00597201132 Fem
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00598706201 Provisional CRA FEM PROV/CUT GDE SZ BML, Rx, Sterile; 0059870620
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00597102010 Provisional CR ART SURF PROV 12/PURPLE 10, Rx, Sterile; 00597102
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00597106126 Provisional MIC POROUS PAT PROV 26MMX10MM, Rx, Sterile; 00597106
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00597502010 Provisional AC ART SURF PROV 12/PUR 10, Rx, Sterile; 00597502012
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00597602010 Articular Surface AC ART SURF 12/PUR 10, Rx, Sterile; 00597602012
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00597601201 Femur CRA PRECOAT FEM COMP SIZE B/L Rx, Sterile; 00597601202 Femu
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: 00597201303 Femur CR POR FM COMP SIZE CML Rx, Sterile; 00597201304 Femur CR
2013-08-28
Class II — Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articula...
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FDA Device Recall: REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, Gle
2013-08-21
Class II — There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to fracture during use and become disassociated from the device. There have been 47 reported comp...
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FDA Device Recall: Bigliani/Flatow¿ The Complete Shoulder Solution, Humeral Stem Provisional 12mm x
2013-07-17
Class II — The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4301-012-17, lot 62283991) as the stems manufactured under the lot are 14mm x 170mm devices i...
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FDA Device Recall: Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 4305-1
2013-07-10
Class II — This is a recall expansion from the 2010 recall which now includes seven additional lots that were not previously included. Zimmer, Inc. is initiating a recall of small and large Fukuda-ty...
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FDA Device Recall: Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Num
2013-04-10
Class II — Possibility that the inner pouch may be compromised. The product is packaged in two pouches - a sterile inner pouch within an external pouch. NexPosure Retractors contained in a breached in...
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FDA Device Recall: Trilogy Acetabular AB Shells with Holes. The Trilogy Acetabular System is ind
2013-02-13
Class II — Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the fir...
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FDA Device Recall: Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is
2013-02-13
Class II — Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the fir...
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FDA Device Recall: Trilogy Acetabular Shells with Holes. The Trilogy Acetabular System is indica
2013-02-13
Class II — Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the fir...
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FDA Device Recall: Trilogy Acetabular AB Shells with Cluster Holes. The Trilogy Acetabular Syste
2013-02-13
Class II — Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the fir...
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FDA Device Recall: The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Ste
2013-01-16
Class II — Zimmer Spine is has received complaints of difficulty in turning the implant release knob of the TM Ardis Inserter after final positioning of the TM Ardis interbody spacer implant. There h...
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FDA Device Recall: Zimmer Spine Ardis Inserter, Rx, non-sterile
2013-01-02
Class I — Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when too much lateral force is applied to the Ardis Inserter. If the PEEK Ardis Interbody Spacer ...
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FDA Recall: Zimmer, Inc. — Class II
20121226
All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide | Product: Persona, The Personalized Knee System,...
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FDA Recall: Zimmer, Inc. — Class II
20121226
Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in t | Product: COONMAD/MORREY TOTAL ELBOW ELBOW COMP...
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FDA Recall: Zimmer, Inc. — Class II
20121226
All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide | Product: Persona The Personalized Knee System, ...
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FDA Recall: Zimmer, Inc. — Class II
20121226
All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide | Product: Persona, The Personalized Knee System,...
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FDA Recall: Zimmer, Inc. — Class II
20121128
Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become diffi | Product: 00789504001 VerSys Femoral Head Provis...
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FDA Recall: Zimmer, Inc. — Class II
20121114
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintert | Product: Dynesys¿ Top-Loading System Cannulated...
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FDA Recall: Zimmer, Inc. — Class II
20121114
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintert | Product: NCB¿ screw ¿ 4.0 self-tapping
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FDA Recall: Zimmer, Inc. — Class II
20121114
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintert | Product: DTO" Implant
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FDA Recall: Zimmer, Inc. — Class II
20121114
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintett | Product: Anatomical Shoulder" Fracture Humeral ...
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FDA Recall: Zimmer, Inc. — Class II
20121024
Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petite (item 00-8011-000-05; ) and CPT Femoral Stem 12/14 | Product: CPT Femoral Stem 12/14 Neck Taper Exte...
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FDA Recall: Zimmer, Inc. — Class II
20121010
Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and pro | Product: 00789502202 VerSys Femoral Head Provis...
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FDA Recall: Zimmer, Inc. — Class II
20120822
Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Rev | Product: 00-4309-029-01 - Trabecular Metal Reve...
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FDA Recall: Zimmer, Inc. — Class II
20120718
Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been received that the rod holder tip may crack or break | Product: Pathfinder NXT Fixed Percutaneous Rod ...
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FDA Device Recall: Persona, The Personalized Knee System, Tibial Broach,, Cemented, Size C-D, No
2012-12-26
Class II — All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being re...
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FDA Device Recall: COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS FOR
2012-12-26
Class II — Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replacement Set...
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FDA Device Recall: Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemme
2012-12-26
Class II — All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being re...
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FDA Device Recall: Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsteri
2012-12-26
Class II — All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being re...
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FDA Device Recall: Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemme
2012-12-26
Class II — All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being re...
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FDA Device Recall: Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemme
2012-12-26
Class II — All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being re...
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FDA Device Recall: Persona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diameter
2012-12-26
Class II — All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being re...
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FDA Device Recall: Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsteri
2012-12-26
Class II — All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being re...
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FDA Device Recall: Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsteri
2012-12-26
Class II — All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being re...
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FDA Device Recall: Persona, The Personalized Knee System, Tibial Broach, Cemented, Size E-F, Non
2012-12-26
Class II — All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being re...
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FDA Device Recall: Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, Non
2012-12-26
Class II — All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being re...
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FDA Device Recall: Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemme
2012-12-26
Class II — All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being re...
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FDA Device Recall: Persona, The Personalized Knee System, Tibial Drill Guide, Cemented, 15.7 mm D
2012-12-26
Class II — All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being re...
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FDA Device Recall: Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular H
2012-12-26
Class II — Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replacement Set...
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FDA Device Recall: 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femora
2012-11-28
Class II — Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes d...
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FDA Device Recall: 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS
2012-11-28
Class II — Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes d...
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FDA Device Recall: 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS
2012-11-28
Class II — Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes d...
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FDA Device Recall: 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12
2012-11-28
Class II — Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes d...
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FDA Device Recall: Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves
2012-11-28
Class II — Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is packaged in the incorrect carton. Product labels and patient labels are correct, matching the...
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FDA Device Recall: 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS
2012-11-28
Class II — Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes d...
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FDA Device Recall: The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Ster
2012-11-28
Class II — Zimmer Trilogy¿ Acetabular System Shell with Cluster Holes, Porous,56 MM O.D., sterile; is missing polar hole threads. Zimmer received one complaint in which no injury was reported.
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FDA Device Recall: . 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femo
2012-11-28
Class II — Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes d...
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FDA Device Recall: 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS
2012-11-28
Class II — Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes d...
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FDA Device Recall: Multipolar¿ Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22 Product Usage:
2012-11-28
Class II — Zimmer Inc. is initiating a removal of the Multipolar¿ Bipolar Cup Liner 22 mm J.D. (item 00-5001-040-22) due to reports that the split poly ring was incorrectly assembled.
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FDA Device Recall: 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS
2012-11-28
Class II — Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes d...
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FDA Device Recall: 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femora
2012-11-28
Class II — Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes d...
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FDA Device Recall: Dynesys¿ Top-Loading System Cannulated Pedicle + Set Screw
2012-11-14
Class II — Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four ...
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FDA Device Recall: NCB¿ screw ¿ 4.0 self-tapping
2012-11-14
Class II — Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four ...
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FDA Device Recall: DTO" Implant
2012-11-14
Class II — Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four ...
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FDA Device Recall: Anatomical Shoulder" Fracture Humeral stem
2012-11-14
Class II — Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four ...
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FDA Device Recall: Alloclassic SL Shaft
2012-11-14
Class II — Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four ...
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FDA Device Recall: Anatomical Shoulder" Inverse/Reverse Humeral PE-Insert Sterile, Rx
2012-11-14
Class II — Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four ...
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FDA Device Recall: Biolox¿ Option Ceramic Femoral Head System Rx, sterile
2012-11-14
Class II — Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four ...
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FDA Device Recall: zimmer Anatomical Shoulder Glenoid S, cemented, sterile; REF 01.04214.340 PE K
2012-11-14
Class II — Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four ...
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FDA Device Recall: Anatomical Shoulder" Inverse Humeral Cup
2012-11-14
Class II — Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four ...
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FDA Device Recall: Anatomical Shoulder" Inverse/Reverse Glenoid Sterile, Rx
2012-11-14
Class II — Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four ...
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FDA Device Recall: Dynesys¿ Revision + set screw
2012-11-14
Class II — Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four ...
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FDA Device Recall: MS-30¿ Stem
2012-11-14
Class II — Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four ...
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FDA Device Recall: Anatomical Shoulder" Humeral stem
2012-11-14
Class II — Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four ...
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FDA Device Recall: MS-30¿ Distal centralizer, cemented, sterile, Rx
2012-11-14
Class II — Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four ...
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FDA Device Recall: CLS Stem
2012-11-14
Class II — Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four ...
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FDA Device Recall: Original M.E. Mueller" Low Profile Cup Sterile, Rx
2012-11-14
Class II — Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four ...
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FDA Device Recall: Anatomical Shoulder" Humeral Head
2012-11-14
Class II — Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four ...
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FDA Device Recall: NCB¿ cancellous screw
2012-11-14
Class II — Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four ...
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FDA Device Recall: Kopf Adapter S Sterile, Rx
2012-11-14
Class II — Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four ...
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FDA Device Recall: Fitmore" Hip Stem
2012-11-14
Class II — Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four ...
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FDA Device Recall: Dynesys¿ HA Pedicle + set screw
2012-11-14
Class II — Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthru, Switzerland, after receiving four ...
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FDA Device Recall: NCB¿-PH Plate
2012-11-14
Class II — Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four ...
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FDA Device Recall: CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CPT s
2012-10-24
Class II — Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petite (item 00-8011-000-05; ) and CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-811...
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FDA Device Recall: CPT Modular Stem, Item No. 00-8011-001-00; Lot 61947708. CPT stems are primar
2012-10-24
Class II — Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petite (item 00-8011-000-05; ) and CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-811...
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FDA Device Recall: CPT Hip System Femoral Stem Petite, Item No. 00-8011-000-05. CPT stems are pr
2012-10-24
Class II — Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petite (item 00-8011-000-05; ) and CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-811...
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FDA Device Recall: 00789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral
2012-10-10
Class II — Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases ...
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FDA Device Recall: 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS
2012-10-10
Class II — Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases ...
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FDA Device Recall: Cemented Tibial Drill Product Usage: The cemented tibial drill is used to pr
2012-10-10
Class II — Zimmer is initiating a recall of the Cemented Tibial Drill for the Zimmer Persona Personalized Knee System due to three reports being received as of August 29. 2012 for tibial cortex perfo...
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FDA Device Recall: 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS
2012-10-10
Class II — Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases ...
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FDA Device Recall: 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS
2012-10-10
Class II — Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases ...
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FDA Device Recall: 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12
2012-10-10
Class II — Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases ...
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FDA Device Recall: 00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femora
2012-10-10
Class II — Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases ...
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FDA Device Recall: 12/14 Neck Taper 00789504001 VerSys Femoral Head Provisional 40mm -3.5 0078950
2012-10-10
Class II — Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases ...
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FDA Device Recall: 00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65¿¿ Neck Angle
2012-08-22
Class II — Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Reverse Shoulder Liner Impactors manufactu...
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FDA Device Recall: Trabecular Metal Reverse Shoulder Liner 40mm, part 00-4309-028-00 - Per surg
2012-08-22
Class II — Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Reverse Shoulder Liner Impactors manufactu...
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FDA Device Recall: The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-steril
2012-08-22
Class II — Zimmer investigation following a complaint found one lot of NCB Polyaxial Locking Plate System NCB screws, 26mm, distributed in the United States contained incorrect 32 mm screws.
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FDA Device Recall: Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF
2012-08-08
Class II — The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Zimmer has received complaints for the spring clip fracturing on the update...
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FDA Device Recall: Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisio
2012-08-08
Class II — The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Zimmer has received complaints for the spring clip fracturing on the update...
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FDA Device Recall: Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight hand
2012-07-18
Class II — Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been received that the rod holder tip may crack or break when the rod is manipulated during surg...
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FDA Device Recall: Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle handle)
2012-07-18
Class II — Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been received that the rod holder tip may crack or break when the rod is manipulated during surge...
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ny_corps
2 records
NY Corp: ZIMMER LLC
2016-01-21
DOMESTIC LIMITED LIABILITY COMPANY | County: Suffolk | Jurisdiction: New York
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NY Corp: ZIMMER PARTNERS, LP
2012-09-05
FOREIGN LIMITED PARTNERSHIP | County: New York | Jurisdiction: Delaware
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OSHA
1 records
OSHA Inspection (Planned) - Zimmer, Inc
1987-07-29
OSHA inspection at Zimmer, Inc, WARSAW, IN. NAICS: 000000. SIC: 3842
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