Home / Recalls / Medical Devices
Zimmer Biomet, Inc. recalls Comprehensive RS Cleat CAP, Item No. 110300
Recalled December 4, 2019 · FDA recall Z-0525-2020 · Zimmer Biomet
Hazard
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. · FDA Class II
Units
219988 units (total)
Sold at
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.
Description
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Product
Comprehensive RS Cleat CAP, Item No. 110300
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →