Reported Oct 20, 2021 · Terminated
United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025
Uoc USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Uoc Usa Inc · 15251 Alton Parkway Ste 100 · Irvine, CA · 92618
Is this the product you have?
- United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025
- Lot codes and dates
- Catalog Number2915-1025
- UDI Code04719872148197
- Lot Code19E272H
- Amount recalled
- 3 devices
Where it was sold
Why it was recalled
Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.
This product could cause temporary or reversible health problems — stop using it.
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