Device product
PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Z-0524-2024
Product summary
- Event
- Event 93329
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 33 devices
- Official record key
device-enforcement:Z-0524-2024
Official wording
Reason: Due to incorrect product labeling
Code information: Product Code: 6539.54.610 UDI-DI Code: 08033390212786 Lot/Sterilization Numbers: 2122621 / 2200149 2203871 / 2200167
Distribution pattern: U.S Distribution: AZ, CA, IL, LA, and NY
Derived failure modes
-
Labeling or packaging
incorrect product labeling