BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0110-2022 · Reported October 20, 2021

    Enforcement

    Recall Number
    Z-0110-2022
    Event ID
    88692
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Uoc Usa Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 20, 2021
    Initiation Date
    August 27, 2021
    Classification Date
    October 13, 2021
    Termination Date
    January 20, 2023
    Address
    15251 Alton Parkway Ste 100, N/A, Irvine, CA, 92618, United States

    Description

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

    Reason

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

    Code Info

    Catalog Number: 2915-1025 UDI Code: 04719872148197 Lot Code: 19E272H

    Distribution

    U.S. Nationwide: CA, CO, and NV No O.U.S.

    Quantity

    3 devices