Zimmer Recalls
550 recalls on record · September 5, 1978 to July 1, 2026 · Medical Devices, Vehicles
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 1, 2024Medical DevicesFDA
Zimmer, Inc. recalls NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
Hazard: 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 substrate.
September 13, 2023Medical DevicesFDA
Zimmer, Inc. recalls M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number
Hazard: The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.
August 9, 2023Medical DevicesFDA
Zimmer, Inc. recalls Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary int
Hazard: 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 screw may not correctly lock.
July 12, 2023Medical DevicesFDA
Zimmer, Inc. recalls NexGen Precoat Stemmed Tibial Plate Size 5
Hazard: Device outer packaging was incorrectly labeled.
April 5, 2023Medical DevicesFDA
Zimmer, Inc. recalls CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip
Hazard: Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in flexion/extension being less than 100 degrees as recommended per an internationally recognized standard (ISO 21535:2009
February 15, 2023Medical DevicesFDA
Zimmer, Inc. recalls Identity Shoulder System Resection Planer 35mm Resection Planer
Hazard: Two planers were found to be unusable during sawbones shoulder training.
December 21, 2022Medical DevicesFDA
Zimmer, Inc. recalls NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02
Hazard: 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 revision rates when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components as compared to other total knee arthroplasties in the United Kingdom National Joint Registry (UK NJR). Removing the NexGen Stemmed Option Tibial Component f rom inventory will prevent its future implantation with either the LPS Flex or LPS Flex GSF femoral components and mitigate the increased revision risk with these two specific combinations of tibial and femoral component.
December 21, 2022Medical DevicesFDA
Zimmer, Inc. recalls NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01
Hazard: 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 revision rates when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components as compared to other total knee arthroplasties in the United Kingdom National Joint Registry (UK NJR). Removing the NexGen Stemmed Option Tibial Component f rom inventory will prevent its future implantation with either the LPS Flex or LPS Flex GSF femoral components and mitigate the increased revision risk with these two specific combinations of tibial and femoral component.
December 21, 2022Medical DevicesFDA
Zimmer, Inc. recalls NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02
Hazard: 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 revision rates when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components as compared to other total knee arthroplasties in the United Kingdom National Joint Registry (UK NJR). Removing the NexGen Stemmed Option Tibial Component f rom inventory will prevent its future implantation with either the LPS Flex or LPS Flex GSF femoral components and mitigate the increased revision risk with these two specific combinations of tibial and femoral component.
December 21, 2022Medical DevicesFDA
Zimmer, Inc. recalls NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01
Hazard: 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 revision rates when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components as compared to other total knee arthroplasties in the United Kingdom National Joint Registry (UK NJR). Removing the NexGen Stemmed Option Tibial Component f rom inventory will prevent its future implantation with either the LPS Flex or LPS Flex GSF femoral components and mitigate the increased revision risk with these two specific combinations of tibial and femoral component.
December 21, 2022Medical DevicesFDA
Zimmer, Inc. recalls NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02
Hazard: 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 revision rates when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components as compared to other total knee arthroplasties in the United Kingdom National Joint Registry (UK NJR). Removing the NexGen Stemmed Option Tibial Component f rom inventory will prevent its future implantation with either the LPS Flex or LPS Flex GSF femoral components and mitigate the increased revision risk with these two specific combinations of tibial and femoral component.
December 21, 2022Medical DevicesFDA
Zimmer, Inc. recalls NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01
Hazard: 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 revision rates when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components as compared to other total knee arthroplasties in the United Kingdom National Joint Registry (UK NJR). Removing the NexGen Stemmed Option Tibial Component f rom inventory will prevent its future implantation with either the LPS Flex or LPS Flex GSF femoral components and mitigate the increased revision risk with these two specific combinations of tibial and femoral component.
October 12, 2022Medical DevicesFDA
Zimmer, Inc. recalls G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip
Hazard: 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-clinically or clinically significant extension of surgery, or infection leading to surgical intervention.
June 9, 2021Medical DevicesFDA
Zimmer GmbH recalls Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CCD Left Ti-6Al-4V Alloy-is intended for temp
Hazard: Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree
June 9, 2021Medical DevicesFDA
Zimmer GmbH recalls Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for tempor
Hazard: Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree
October 9, 2019Medical DevicesFDA
Zimmer GmbH recalls Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Ste
Hazard: Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.
May 29, 2019Medical DevicesFDA
Zimmer GmbH recalls CBS high, countersink, cannulated, AO, Item Number ST503004542
Hazard: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
May 29, 2019Medical DevicesFDA
Zimmer GmbH recalls CBS micro, countersink, cannulated, AO, Item Number ST503004541
Hazard: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
May 29, 2019Medical DevicesFDA
Zimmer GmbH recalls Drill, contra-angle, 1.5x85mm, Item Number ST502015706
Hazard: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
May 29, 2019Medical DevicesFDA
Zimmer GmbH recalls Drill, 3.2x145mm, AO, Item Number ST502015650
Hazard: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
May 29, 2019Medical DevicesFDA
Zimmer GmbH recalls Drill, cannulated, 4x90mm, round shaft, Item Number ST502015640
Hazard: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
May 29, 2019Medical DevicesFDA
Zimmer GmbH recalls Drill, cannulated, 3.5x90mm, round shaft, Item Number ST502015635
Hazard: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
May 29, 2019Medical DevicesFDA
Zimmer GmbH recalls Drill, cannulated, 3x90mm, AO, Item Number ST502015631
Hazard: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
May 29, 2019Medical DevicesFDA
Zimmer GmbH recalls Drill, cannulated, 3x90mm, round shaft, Item Number ST502015630
Hazard: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
May 29, 2019Medical DevicesFDA
Zimmer GmbH recalls Drill, cannulated, 2.8x120mm, AO, Item Number ST502015628
Hazard: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
May 29, 2019Medical DevicesFDA
Zimmer GmbH recalls Drill, cannulated, 2x95mm, AO, Item Number ST502015623
Hazard: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
May 29, 2019Medical DevicesFDA
Zimmer GmbH recalls Drill, cannulated, 2.5x95mm, AO, Item Number ST502015621
Hazard: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
May 29, 2019Medical DevicesFDA
Zimmer GmbH recalls Drill, cannulated, 2.5x95mm, round shaft, Item Number ST502015620
Hazard: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
May 29, 2019Medical DevicesFDA
Zimmer GmbH recalls Drill, cannulated, 2x95mm, round shaft, Item Number ST502015619
Hazard: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
May 29, 2019Medical DevicesFDA
Zimmer GmbH recalls Drill, cannulated, 4x150mm, AO, Item Number ST502015403
Hazard: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.