BEUDAMED
    FDA Enforcement Class II Terminated

    SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928

    Recall: Z-0922-2021 · Reported February 3, 2021

    Enforcement

    Recall Number
    Z-0922-2021
    Event ID
    87062
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    OMNIlife science Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 3, 2021
    Initiation Date
    December 21, 2020
    Classification Date
    January 26, 2021
    Termination Date
    June 10, 2021
    Address
    480 Paramount Dr, Raynham, MA, 02767-1085, United States

    Description

    SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928

    Reason

    Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery

    Code Info

    Lot Number: 28572

    Distribution

    AL, ID, MD, NY, OK

    Quantity

    2 units