Recall archive
245 recalls · page 4 of 11
Reported Mar 6, 2019
Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 23, 2019
Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — There is a potential for silicone shedding during cleaning and sterilization.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 16, 2019
Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Product Usage: The system is intended for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand · Product · Product details — One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 26, 2018
NexGen¿ Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Screw is missing from the package
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 19, 2018
Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
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 recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 12, 2018
Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
13 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 28, 2018
Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Label on the outer carton or the patient labels does not match label on the inner sterile packaging
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 21, 2018
Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Affixus Hip Fracture Nail System, comprised of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — The set screw is not able to advance or reverse from the original position in the nail.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 14, 2018
Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020 Used for the re-attachment of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand · Product · Product details — Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 7, 2018
EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Zimmer Biomet, Inc.
Matched: Brand — Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 24, 2018
Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product Usage: Intended for the fixation of fractures
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
47 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 17, 2018
OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Orthosensor, Inc.
Matched: Product · Product details — Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 3, 2018
HipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-130-004…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet UK Ltd.
Matched: Brand — HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 3, 2018
Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage - The Zimmer Natural Nail System…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — The item is labeled as an 8.3mm, but it is actually a 12 mm.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 26, 2018
Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 19, 2018
Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 280 mm, Item Number: 814309280
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — The set screw is not able to advance or reverse from the original position in the nail.
128 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 12, 2018
Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — A size 22mm threaded peg was found in the package of a 10mm unit.
FDA (openFDA device enforcement)
Reported Aug 29, 2018
Connecting Bolt, Model 14-442093
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Product was manufactured from the incorrect material, which shows a potential decrease in the fatigue strength of the connecting bolt that can lead…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 22, 2018
ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 11, 2018
Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset, 00-7711-004-40
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the…
14 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 4, 2018
Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing…
FDA (openFDA device enforcement)
Reported Jun 27, 2018
DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin for insertion of implants (cannulated screws…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of…
12 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 20, 2018
Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand · Product · Product details — One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 23, 2018
Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected…
3 more products in this recall
FDA (openFDA device enforcement)
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