Zimmer Biomet Recalls Polyethylene Implants Due to High Endotoxin Levels
Zimmer Biomet is recalling Repicci II Tibial Components for partial knee replacement because endotoxin levels exceeded process maximum limits.
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 injuries or illnesses 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 various polyethylene implants, specifically the Sports Med Repicci II Tibial Components used for partial knee replacement. The recall was initiated because endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
The recall affects 28,253 units in total. These 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. The specific items and lots involved are Item 102140 (372580), Item 102152 (361720), Item 102160 (347140), Item 102168 (129360), Item 102176 (129370), and Item 102178 (866150).
Consumers and healthcare providers should contact Zimmer Biomet, Inc. for further instructions regarding the return or replacement of these devices. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement
- 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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