Z-0110-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 20, 2021
- Initiation Date
- August 27, 2021
- Termination Date
- January 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 devices
Product Description
United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025
Reason for Recall
Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.
Distribution Pattern
U.S. Nationwide: CA, CO, and NV No O.U.S.
Code Information
Catalog Number: 2915-1025 UDI Code: 04719872148197 Lot Code: 19E272H