Recall archive
156 recalls · page 5 of 7
Reported Apr 26, 2017
various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 19, 2017
MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning and orientation of instrument holders or tool…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Unapproved change made by the supplier.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 29, 2017
Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Digital templates were created with the incorrect files.
FDA (openFDA device enforcement)
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 — 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 Jul 27, 2016
TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand · Product · Product details — The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a foreign body if the fractured screw…
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 — 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 Jun 1, 2016
PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.
14 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 13, 2016
All instrumentation associated with the Prelude PF Resurfacing Knee System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — Inadequate design control.
FDA (openFDA device enforcement)
Reported Apr 6, 2016
Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — The anterior/posterior (AP) dimension may be oversized by 0.016 . If the femoral component does not fit as tightly as intended, bony ingrowth may not…
FDA (openFDA device enforcement)
Reported Mar 16, 2016
Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — Components of the DVR ePAKs can oxidize during shipment and storage prior to use. A delay in surgery, less than 30 minutes, may occur if the surgical…
1 more product in this recall
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
HipLOC CHS Plate/Lag Screw Introducer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the introducor coupling screw. It appears…
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
Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand · Product · Product details — PMMA is listed as a material on the label but the product does not contain PMMA.
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 · 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)
Reported Dec 30, 2015
A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — These screws have a single lead (instead of a triple lead) thread. The screw may sit proud in the plate, If the screw does not lock into the plate;…
2 more products in this recall
FDA (openFDA device enforcement)
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