Zimmer Biomet Recalls Polyethylene Implants Due to High Endotoxin Levels
Zimmer Biomet is recalling 28,253 custom polyethylene implants because endotoxin levels exceeded process maximum limits. The affected parts 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) that poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria 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 custom polyethylene implants. The recall was initiated because endotoxin levels in the identified polyethylene components were discovered to be higher than process maximum limits.
The affected products were distributed worldwide, including in the United States, Argentina, Australia, Canada, Chile, China, Costa Rica, Ecuador, India, Italy, Japan, South Korea, Malaysia, Mexico, Panama, Singapore, Switzerland, Thailand, and the United Kingdom.
Consumers and healthcare providers should stop using the affected polyethylene components and contact Zimmer Biomet for further instructions on the recall.
The recalled product
- Product
- various polyethylene implants Custom parts Product Usage: Custom
- 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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