Device product
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Z-1261-2023
Product summary
- Event
- Event 91613
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5 systems
- Official record key
device-enforcement:Z-1261-2023
Official wording
Reason: Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
Code information: Product Code: 1590.15.010 UDI-DI Code: 08033390128865 Lot Number: 2115522 Sterilization Lot Number: 2100241
Distribution pattern: U.S. Distribution to: TX
Derived failure modes
-
Unknown
Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.