Zimmer Biomet Recalls Polyethylene Knee Implants Due to Endotoxin Levels
Zimmer Biomet is recalling 28,253 polyethylene knee implants because endotoxin levels exceeded process maximum limits. The affected products were distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a contamination hazard (endotoxin) where no illnesses or injuries have been reported, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 28,253 units of various polyethylene implants used in knee surgeries, including the Vanguard Complete Knee System, Oxford Partial Knee, and Biomet Patella. The recall was initiated because endotoxin levels in the identified polyethylene components were discovered to be higher than process maximum limits.
The affected products are intended for use in total knee arthroplasty, limb salvage joint reconstruction, and partial knee replacement. The recall covers distribution in the United States and numerous international locations, including Argentina, Australia, Canada, China, India, Japan, and the United Kingdom.
Consumers and healthcare providers should contact Zimmer Biomet for further instructions on how to handle the affected implants. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Va
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 28,253
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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