Device product
TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
Z-1653-2023
Product summary
- Event
- Event 92257
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 24 units in total
- Official record key
device-enforcement:Z-1653-2023
Official wording
Reason: 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
Code information: GTIN: 07613327390698 Lot Number: JH3AHJ
Distribution pattern: US Nationwide - Worldwide Distribution: CT, FL, IN, KY, MT, NJ, OR, PA, SC Foreign: China, Japan
Derived failure modes
-
Labeling or packaging
Mislabeled