Zimmer Biomet Recalls Comprehensive RS Cleat CAP Due to Contamination
Zimmer Biomet is recalling Comprehensive RS Cleat CAP devices because elevated levels of bacterial endotoxin and residual debris remain on the products due to a cleaning issue.
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 risk of harm (bacterial endotoxin and debris) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling the Comprehensive RS Cleat CAP, Item No. 110300. The recall is being conducted because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
The affected products were distributed nationwide in the United States and in several international countries, including Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela. The total quantity of units involved is 219,988.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Comprehensive RS Cleat CAP, Item No. 110300
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 219,988
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 126590 126600 502890 502900 502910 012080 941080
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 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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