Recall archive
245 recalls · page 7 of 11
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 28, 2016
3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand — Product was incorrectly packaged.
FDA (openFDA device enforcement)
Reported Sep 14, 2016
Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet Microfixation, LLC
Matched: Brand — Potential sterility deficiency.
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 Aug 24, 2016
Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H) Item: IWTH52 Dental implants
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand — Pouches may not have been sealed during packing.
118 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 24, 2016
OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nidek Inc.
Matched: Product · Product details — Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement.
FDA (openFDA device enforcement)
Reported Aug 17, 2016
Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet Spine, Inc.
Matched: Brand · Reason for recall — Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrument Case and Zyston¿ Transform Implant Kit because the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 10, 2016
TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer GmbH
Matched: Reason for recall — Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the…
3 more products in this recall
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 22, 2016
POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 00587806535 POROUS PATELLA 38MM X 10MM -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Trabecular Metal Technology, Inc.
Matched: Reason for recall — Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011…
5 more products in this recall
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
10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230. Product Usage: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet Spine, LLC
Matched: Brand · Reason for recall — Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mislabeled lordotic angle of 12degrees when the angle…
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 30, 2016
Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stability required for solid bone fusion and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Spine, Inc.
Matched: Reason for recall — Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct¿…
1 more product in this recall
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 9, 2016
Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Spine, Inc.
Matched: Reason for recall — Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fixation System by providing additional guidance in the…
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 Feb 17, 2016
Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical procedures.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet France SARL
Matched: Brand · Product · Product details — Cytotoxicity tests were not passed at 36 months. Use of Endobon-Xenograft Granules past 18 months of its specified shelf life may result in patient…
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)
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