Recall Z-0525-2020— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2019-08-21, terminated 2021-07-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Comprehensive RS Cleat CAP, Item No. 110300. Reason: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-08-21
- Terminated
- 2021-07-21
- Firm location
- Warsaw, IN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.