FDA-Device2021-10-20Class II
United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025
Uoc Usa Inc
Hazard
Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.
Sold states
U.S. Nationwide: CA, CO, and NV No O.U.S.
Affected count
3 devices
Manufactured in
15251 Alton Parkway Ste 100, N/A, Irvine, CA, United States
Products
United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0110-2022Don't want to check this manually?
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