Medical device recalls Moderate risk

Uoc Usa Inc recalls United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025

Recall date
August 27, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0110-2022
FDA classification
Class II
Brand / firm
Uoc Usa Inc
Sold / distributed
U.S. Nationwide: CA, CO, and NV No O.U.S.

Why it was recalled

Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025

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