Device product
NexGen Precoat Stemmed Tibial Plate Size 5
Z-2092-2023
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 92531
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-2092-2023
Official wording
Reason: Device outer packaging was incorrectly labeled.
Code information: Model No. 00598004701; UDI No./Lot. No.: (01)00889024217607(17)321228(10)J7418537/J7418537 and (01)00889024217607(17)321228(10)J7418542/J7418542.
Distribution pattern: International distribution in the country of India.
Derived failure modes
-
Labeling or packaging
incorrectly labeled