Zimmer Biomet Recalls
875 recalls on record · January 20, 2016 to December 30, 2020 · Medical Devices
Recalls by year
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20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 25, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL Ma
Hazard: Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery.
January 18, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminu
Hazard: Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mislabeling. Zimmer Biomet received product complaints reporting that when the package labeled as a Right was opened it actually contained a Left Bearing.
November 2, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
Hazard: Complaints have been reported that the handpiece is inoperable. The investigation found that the complaints were related to the lack of preventative maintenance contrary to what is recommended in the instructions for use included with the handpiece. An inoperable device may lead to a delay in surgery
October 26, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and disabled knee joint resulting from osteoar
Hazard: Contents of the package do not match the product labeling. Product is labeled: Vanguard Distal Femoral Augment 75 X 5 RL/LM Carton contains: Vanguard Distal Femoral Augment 75 X 5 LL/RM Risks: Adverse health outcomes that could occur as a result of this event are a delay less than 30 minutes and a different size augment being used to complete the procedure. As the augment will not assemble with femoral component due to its shape, it would be easily identified during surgery.
October 26, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smooth A 467265-01 Ball Tip Guide Pin is used
Hazard: The G-PIN 2.8BL 3.2PL 60 CM 2PK is intended to contain one (1) 467265-01 Ball Tip Guide Pin and one (1) 467255-02 Plain Tip Guide Pin. The G-PIN 2.8BL 3.2PL 60 CM 2PK may have been packaged incorrectly either with two (2) 467265-01 Ball Tip Guide Pins and zero (0) 467255-02 Plain Tip Guide Pins or with zero (0) 467265-01 Ball Tip Guide Pins and two (2) 467255-02 Plain Tip Guide Pins. If the G-PIN 2.8BL 3.2PL 60 CM 2PK contains the incorrect combination of Plain Tip Guide Pins and Ball Tip Guide Pins, the surgeon would either have to implant the nail without the Plain Tip Guide Pin as a guide, ream with a Plain Tip Guide Pin, or choose to not ream the humeral canal. The risk associated with not having the correct combination can include a delay in surgery of less than 30 minutes, the reamer tip remaining in the distal humeral canal, or an iatrogenic fracture.
October 19, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls Phoenix Recon Targeting Arm Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for t
Hazard: Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into the old revision targeting arm. The old revision tissue sleeve has too much clearance with new revision targeting arm. Risks of encountering the affected product include: the correct instrument may not be readily available for the procedure causing the surgeon to complete the procedure by hand; or a delay in surgery greater than 30 minutes may occur while another Recon Targeting Arm or Recon Soft tissue Sleeve is located or while the surgeon completes the procedure by hand.
October 19, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments
Hazard: Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into the old revision targeting arm. The old revision tissue sleeve has too much clearance with new revision targeting arm. Risks of encountering the affected product include: the correct instrument may not be readily available for the procedure causing the surgeon to complete the procedure by hand; or a delay in surgery greater than 30 minutes may occur while another Recon Targeting Arm or Recon Soft tissue Sleeve is located or while the surgeon completes the procedure by hand.
October 12, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls Vanguard 360 Revision Knee System Knee prostheses
Hazard: The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included in the Vanguard 360 Revision Knee System was larger than allowable per the process specification. As a result, the hex geometry can still be visible, but there are radial cuts into the hex flat. Therefore, when the bolt is inserted into the augment, the screwdriver is unable to catch on the hex geometry, or the screwdriver strips the remaining hex geometry, and the bolt is unable to be fully tightened. The bolt stripping or the bolt not being fully tightened will be noticed by the surgeon intraoperatively when he or she is unable to screw the augment bolts into the augment. This possible event can result in an intraoperative delay resulting in increased time under anesthesia.
September 14, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts are placed
Hazard: Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small because the lot was packaged with a missing humeral bushing. The missing bushing could result in a surgical delay or additional surgery if a replacement is not available.
June 15, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facil
Hazard: Zimmer Inc. is initiating a recall of specific Persona" Trabecular Metal" Tibial Plate Instruments and Modular Brackets, due to incidents of radiolucent lines and loosening in implants.
March 16, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093
Hazard: Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rather than EXT. The product packaging is labeled correctly as Extended. Offset, and the device is an extended offset stem.
March 2, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads Noninflammatory degenerative joint disease (
Hazard: LDPE bag containing the implant adheres to the highly polished implant surface.
March 2, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8 INCH BEADED FC 2 prosthesis,
Hazard: LDPE bag containing the implant adheres to the highly polished implant surface.
March 2, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement
Hazard: LDPE bag containing the implant adheres to the highly polished implant surface.
March 2, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls VERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement
Hazard: LDPE bag containing the implant adheres to the highly polished implant surface.
March 2, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement
Hazard: LDPE bag containing the implant adheres to the highly polished implant surface.
March 2, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented various siz
Hazard: LDPE bag containing the implant adheres to the highly polished implant surface.
March 2, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes "The CPT Hip System
Hazard: LDPE bag containing the implant adheres to the highly polished implant surface.
March 2, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes The CPT Hip System i
Hazard: LDPE bag containing the implant adheres to the highly polished implant surface.
March 2, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various siz
Hazard: LDPE bag containing the implant adheres to the highly polished implant surface.
March 2, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained
Hazard: LDPE bag containing the implant adheres to the highly polished implant surface.
March 2, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femoral prosthesis, knee, patello/femorotibial
Hazard: LDPE bag containing the implant adheres to the highly polished implant surface.
March 2, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/me
Hazard: LDPE bag containing the implant adheres to the highly polished implant surface.
March 2, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GSM NP Flex Natural Knee GSM
Hazard: LDPE bag containing the implant adheres to the highly polished implant surface.
March 2, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer
Hazard: LDPE bag containing the implant adheres to the highly polished implant surface.
March 2, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer various siz
Hazard: LDPE bag containing the implant adheres to the highly polished implant surface.
March 2, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen Knee LPS Porous Fem NexGen Kne
Hazard: LDPE bag containing the implant adheres to the highly polished implant surface.
March 2, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM prosthesis, knee, patellofemorotibial, sem
Hazard: LDPE bag containing the implant adheres to the highly polished implant surface.
March 2, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented
Hazard: LDPE bag containing the implant adheres to the highly polished implant surface.
March 2, 2016Medical DevicesFDA
Zimmer Biomet, Inc. recalls NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained
Hazard: LDPE bag containing the implant adheres to the highly polished implant surface.