Recall archive
85 recalls · page 2 of 4
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 · Product · Product details — 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 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 · Product · Product details — 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 · Product · Product details — 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)
Reported May 16, 2018
Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on the threading after deburring operations. This…
6 more products in this recall
FDA (openFDA device enforcement)
Reported May 9, 2018
Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/polymer semi-constrained cemented…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand · Product · Product details — Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 2, 2018
M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only; Item Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Potential failure of sterile packaging seal.
12 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 25, 2018
Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand · Product · Product details — There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately…
FDA (openFDA device enforcement)
Reported Apr 11, 2018
A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — The drill guides were manufactured with the incorrect color anodization.
FDA (openFDA device enforcement)
Reported Apr 4, 2018
Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand · Product · Product details — Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper…
19 more products in this recall
FDA (openFDA device enforcement)
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