BEUDAMED
    FDA Enforcement Class II Ongoing

    EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.

    Recall: Z-0126-2023 · Reported November 2, 2022

    Enforcement

    Recall Number
    Z-0126-2023
    Event ID
    90882
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Encore Medical, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 2, 2022
    Initiation Date
    August 12, 2022
    Classification Date
    October 21, 2022
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    Description

    EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.

    Reason

    Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.

    Code Info

    UDI-DI/Lot: 00888912167055/132T1085

    Distribution

    US Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX.

    Quantity

    18