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Zimmer Biomet, Inc. recalls Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A
Recalled December 4, 2019 · FDA recall Z-0524-2020 · 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 HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →