Comprehensive RS Cleat CAP, Item No. 110300
Reported: December 4, 2019 Initiated: August 21, 2019 #Z-0525-2020
Product Description
Comprehensive RS Cleat CAP, Item No. 110300
Reason for Recall
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 219988 units (total)
- Distribution
- US Nationwide distribution and countries of 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.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Comprehensive RS Cleat CAP, Item No. 110300. Recalled by Zimmer Biomet, Inc.. Units affected: 219988 units (total).
Why was this product recalled? ▼
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 4, 2019. Severity: Moderate. Recall number: Z-0525-2020.
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