Device product
United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025
Z-0110-2022
Product summary
- Firm
- Uoc Usa Inc
- Event
- Event 88692
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 devices
- Official record key
device-enforcement:Z-0110-2022
Official wording
Reason: Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.
Code information: Catalog Number: 2915-1025 UDI Code: 04719872148197 Lot Code: 19E272H
Distribution pattern: U.S. Nationwide: CA, CO, and NV No O.U.S.
Derived failure modes
-
Unknown
Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.