United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025
Reported: October 20, 2021 Initiated: August 27, 2021 #Z-0110-2022
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.
Details
- Recalling Firm
- Uoc Usa Inc
- Units Affected
- 3 devices
- Distribution
- U.S. Nationwide: CA, CO, and NV No O.U.S.
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025. Recalled by Uoc Usa Inc. Units affected: 3 devices.
Why was this product recalled? ▼
Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 20, 2021. Severity: Moderate. Recall number: Z-0110-2022.
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