Recall Z-0524-2020— Zimmer Biomet, Inc.

Name: FDA recall Z-0524-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-21

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 HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A. 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 HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A

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.