Recall archive
85 recalls · page 4 of 4
Reported Feb 22, 2017
Comprehensive Reverse Shoulder System Humeral Tray Model 115340
High riskUsing this product could cause serious injury, illness or death — stop using it now.Zimmer Biomet, Inc.
Matched: Brand — Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 8, 2017
Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 25, 2017
RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 18, 2017
Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand · Reason for recall — Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mislabeling. Zimmer Biomet received product complaints…
FDA (openFDA device enforcement)
Reported Nov 2, 2016
Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand · Product · Product details — Complaints have been reported that the handpiece is inoperable. The investigation found that the complaints were related to the lack of preventative…
FDA (openFDA device enforcement)
Reported Oct 26, 2016
Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smooth A 467265-01 Ball Tip Guide Pin is used to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 19, 2016
Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 12, 2016
Vanguard 360 Revision Knee System Knee prostheses
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Sep 14, 2016
Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts are placed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand · Reason for recall — Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra…
FDA (openFDA device enforcement)
Reported Jun 15, 2016
Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand · Reason for recall — Zimmer Inc. is initiating a recall of specific Persona" Trabecular Metal" Tibial Plate Instruments and Modular Brackets, due to incidents of…
FDA (openFDA device enforcement)
Reported Mar 16, 2016
M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand · Reason for recall — 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,…
FDA (openFDA device enforcement)
Reported Mar 2, 2016
LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Various…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — LDPE bag containing the implant adheres to the highly polished implant surface.
20 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 20, 2016
Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand · Product · Product details · Reason for recall — Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through product testing that the staking of the set screw was…
2 more products in this recall
FDA (openFDA device enforcement)
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