Recall archive
245 recalls · page 6 of 11
Reported Sep 20, 2017
Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Complaints were received reporting the system would freeze/shut down while in Fulgurate mode.
FDA (openFDA device enforcement)
Reported Aug 9, 2017
ROSA Brain, 3.0.0 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 — Complaint of the head holder connector locking up mechanically when tightened.
FDA (openFDA device enforcement)
Reported Jun 21, 2017
Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand · Reason for recall — Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to…
42 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 14, 2017
Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet Spine Inc.
Matched: Brand · Reason for recall — Zimmer Biomet is conducting a medical device recall for Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs because when…
FDA (openFDA device enforcement)
Reported Jun 7, 2017
Reusable instruments in the Knee, Hip, Trauma, and Extremities segments.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Durability characteristics of reusable instruments were not established
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 31, 2017
10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of…
High riskUsing this product could cause serious injury, illness or death — stop using it now.EBI Patient Care, Inc.
Matched: Reason for recall — Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 24, 2017
Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet Microfixation, LLC
Matched: Brand · Product · Product details — Part of the number on the tray lid differ from the part number on the base.
FDA (openFDA device enforcement)
Reported May 24, 2017
NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
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 lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints…
FDA (openFDA device enforcement)
Reported May 17, 2017
Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand · Reason for recall — 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…
2 more products in this recall
FDA (openFDA device enforcement)
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 Apr 5, 2017
BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product · Product details — A single lot of product that potentially has a single part within the lot that does not match the product on the label due to a commingle at the firm…
FDA (openFDA device enforcement)
Reported Apr 5, 2017
Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet Spine, Inc.
Matched: Brand · Reason for recall — Zimmer Biomet is recalling the Altius M-INI OCT Posterior Spinal Fixation System because the driver is unable to mate with the screw head tulip.
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 Mar 1, 2017
Oxford Knee System Tibial Resector Body Tube & Guides Product Usage: Instruments for use with the Oxford Uni Partial…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet U.K., Ltd.
Matched: Brand · Reason for recall — Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the…
23 more products in this recall
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 Dec 28, 2016
BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product · Product details — A limited number of product pouches may not have been sealed during packaging.
35 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 16, 2016
Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged inside of a padded-foam…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Surgical Inc.
Matched: Reason for recall — Zimmer Biomet Surgical has received product complaints reporting that the surface coating applied to the device is blistering, peeling and…
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)
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