Zimmer Biomet Recalls Polyethylene Implants Due to High Endotoxin Levels
Zimmer Biomet is recalling 28,253 polyethylene implants for shoulder and elbow replacements 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 the source text does not report any illnesses or injuries, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 28,253 polyethylene implants used in the BioModular Shoulder System, Comprehensive Shoulder System, and Comprehensive Reverse Shoulder System. These components are used for shoulder and elbow replacement surgeries.
The recall was initiated because endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. The affected items 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 UK.
Consumers and healthcare providers should contact Zimmer Biomet for instructions on how to proceed with the recall. The source text does not specify specific actions for patients who have already received these implants.
The recalled product
- Product
- various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System Product Usage: Shoulder Replacement Elbow 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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