FDA-Device2019-12-04Class II
Comprehensive RS Cleat CAP, Item No. 110300
Zimmer Biomet, Inc.
Hazard
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Sold states
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.
Affected count
219988 units (total)
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
Comprehensive RS Cleat CAP, Item No. 110300
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0525-2020Don't want to check this manually?
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