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.
March 4, 2015Medical DevicesFDA
Zimmer Gmbh recalls Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient conditions of non-inflammatory deg
Hazard: 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 there is contamination present, a periprosthetic infection is possible, which could lead to revision.
March 4, 2015Medical DevicesFDA
Zimmer Gmbh recalls CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing prima
Hazard: 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 there is contamination present, a periprosthetic infection is possible, which could lead to revision.
March 4, 2015Medical DevicesFDA
Zimmer Gmbh recalls Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction with compatible acetabular and
Hazard: 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 there is contamination present, a periprosthetic infection is possible, which could lead to revision.
March 4, 2015Medical DevicesFDA
Zimmer Gmbh recalls Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of
Hazard: 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 there is contamination present, a periprosthetic infection is possible, which could lead to revision.
March 4, 2015Medical DevicesFDA
Zimmer Gmbh recalls CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the
Hazard: 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 there is contamination present, a periprosthetic infection is possible, which could lead to revision.
February 11, 2015Medical DevicesFDA
Zimmer, Inc. recalls Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279
Hazard: 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 prevent this, TASP shims must be manually cleaned and inspected per product insert, 87-6203-991-22.
February 11, 2015Medical DevicesFDA
Zimmer, Inc. recalls Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthropla
Hazard: Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x 3.5mm in size. Retained tip may result in: pain, soft tissue irritation, soft tissue damage, or increased wear due to contact with the fractured tip; Revision surgery to remove the fractured tip
January 7, 2015Medical DevicesFDA
Zimmer, Inc. recalls Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic
Hazard: 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. Visually these samples do not meet the requirements of ZWI 43.109 and corresponding visual aid 55-0000-310-01.
December 31, 2014Medical DevicesFDA
Zimmer, Inc. recalls Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach Inserter/Extractor Handle is a
Hazard: 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 Persona Cemented Tibial Broach Inserter/Extractor Handle lot 62085420 was missing after broaching the tibia. Postoperative radiographs were inspected and the magnet cover was not identified. The investigation indi
December 17, 2014Medical DevicesFDA
Zimmer, Inc. recalls Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile. The Screw Remover is a comp
Hazard: 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 removal, which could delay surgery up to 30 minutes.
December 3, 2014Medical DevicesFDA
Zimmer, Inc. recalls Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor pads are used in conjunction wi
Hazard: 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 pad fracture.
December 3, 2014Medical DevicesFDA
Zimmer, Inc. recalls Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial
Hazard: 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 pad fracture.
November 19, 2014Medical DevicesFDA
Zimmer, Inc. recalls Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain
Hazard: Cleaning process validation failure.
October 29, 2014Medical DevicesFDA
Zimmer, Inc. recalls The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arth
Hazard: Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.
October 29, 2014Medical DevicesFDA
Zimmer, Inc. recalls Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Met
Hazard: The affected products are missing polar boss threads.
October 8, 2014Medical DevicesFDA
Zimmer, Inc. recalls Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized using irradiation, singl
Hazard: 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.
September 10, 2014Medical DevicesFDA
Zimmer, Inc. recalls Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number 6290-00-704. Per the Natural-Knee
Hazard: Zimmer received a trend of complaints indicating corrosion of product.
September 10, 2014Medical DevicesFDA
Zimmer, Inc. recalls Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number: 6290-00-703. Per the Natural-Knee
Hazard: Zimmer received a trend of complaints indicating corrosion of product.
September 10, 2014Medical DevicesFDA
Zimmer, Inc. recalls Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number: 6290-00-702. Per the Natural-Kne
Hazard: Zimmer received a trend of complaints indicating corrosion of product.
September 10, 2014Medical DevicesFDA
Zimmer, Inc. recalls Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690. Per the Natural-Knee
Hazard: Zimmer received a trend of complaints indicating corrosion of product.
September 10, 2014Medical DevicesFDA
Zimmer, Inc. recalls PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top; Left Size 4-11 EF To
Hazard: 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 that all distributors and users of this instrument are aware of the enhanced surgical techniques.
September 10, 2014Medical DevicesFDA
Zimmer, Inc. recalls PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top; Size 6-9 CD Top;
Hazard: 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 that all distributors and users of this instrument are aware of the enhanced surgical techniques.
September 10, 2014Medical DevicesFDA
Zimmer, Inc. recalls PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the following: Size CD +0 mm Thickne
Hazard: 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 that all distributors and users of this instrument are aware of the enhanced surgical techniques.
September 10, 2014Medical DevicesFDA
Zimmer, Inc. recalls PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional with the following: Left Size 3-9 CD Top; L
Hazard: 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 that all distributors and users of this instrument are aware of the enhanced surgical techniques.
September 10, 2014Medical DevicesFDA
Zimmer, Inc. recalls PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the
Hazard: 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 that all distributors and users of this instrument are aware of the enhanced surgical techniques.
September 10, 2014Medical DevicesFDA
Zimmer, Inc. recalls PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD +0
Hazard: 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 that all distributors and users of this instrument are aware of the enhanced surgical techniques.
September 3, 2014Medical DevicesFDA
Zimmer, Inc. recalls Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM S
Hazard: Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
September 3, 2014Medical DevicesFDA
Zimmer, Inc. recalls Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FNSTRD HIP 41HDX127ST FNSTRD HIP 42HDX127ST
Hazard: Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
September 3, 2014Medical DevicesFDA
Zimmer, Inc. recalls Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG TUBE & SCP PLT 90DX255LG TUBE & SCP PLT 9
Hazard: Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
September 3, 2014Medical DevicesFDA
Zimmer, Inc. recalls Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0X105LG CANN BONE SCR
Hazard: Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.