FDA-Device2023-06-07Class II
TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
Howmedica Osteonics Corp.
Hazard
Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa
Sold states
US Nationwide - Worldwide Distribution: CT, FL, IN, KY, MT, NJ, OR, PA, SC Foreign: China, Japan
Affected count
24 units in total
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1653-2023Don't want to check this manually?
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