Zimmer Biomet Recalls
875 recalls on record · January 20, 2016 to December 30, 2020 · Medical Devices
Recalls by year
16
17
18
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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.
June 21, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Fem IM Nail 16mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Hazard: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
June 21, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Fem IM Nail 15mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Hazard: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
June 21, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Fem IM Nail 16mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Hazard: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
June 21, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Fem IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Hazard: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
June 21, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Fem IM Nail 16mmdx42cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Hazard: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
June 21, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Fem IM Nail 16mmdx40cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Hazard: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
June 21, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Hazard: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
June 21, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implan
Hazard: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
June 7, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET p
Hazard: Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System after it was determined that two pieces from the lot were moved to finished goods and shipped despite having an open Non-Conformance Report (NCR). The NCR indicated that one piece from the lot had scratches and the other non-confirming threads.
June 7, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is intended to treat stable and unstable proxi
Hazard: nail not properly engaging with the targeting jig due to certain undersized specification
June 7, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Reusable instruments in the Knee, Hip, Trauma, and Extremities segments.
Hazard: Durability characteristics of reusable instruments were not established
May 24, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
Hazard: Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorrect.
May 17, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG S
Hazard: pegs shearing post-operatively
May 17, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Bone Dowell Harvest Tubes
Hazard: mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously substituted and etched as 8mm for the actual 8mm subcomponent part.
May 17, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
Hazard: Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. A breach in the packaging could lead to loss of sterility of the device.
April 26, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement
Hazard: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
April 26, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls various polyethylene implants Custom parts Product Usage: Custom
Hazard: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
April 26, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Van
Hazard: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
April 26, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper
Hazard: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
April 26, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder Sy
Hazard: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
April 26, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional spe
Hazard: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
April 19, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument holders or to
Hazard: Unapproved change made by the supplier.
April 19, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning and orientation of instrument holders or tool
Hazard: Unapproved change made by the supplier.
March 29, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic s
Hazard: Digital templates were created with the incorrect files.
February 22, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls 1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
Hazard: The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole.
February 22, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263
Hazard: Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.
February 22, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Comprehensive Reverse Shoulder System Humeral Tray Model 115340
Hazard: Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.
February 8, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL
Hazard: packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left). Risk delay in surgery.
February 8, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System T
Hazard: labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The mislabeling could have the potential risks: A delay in surgery less than 30 minutes. Patient undergoes a revision with increased risk of infection.
January 25, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152
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.