Device product
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Z-1456-2024
Product summary
- Event
- Event 94222
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-1456-2024
Official wording
Reason: Product incorrectly labelled.
Code information: Model No: 150621006; UDI-DI: 10603295507451; Lot JA06A0252.
Distribution pattern: Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the country of Canada.
Derived failure modes
-
Unknown
Product incorrectly labelled.