BEUDAMED
    FDA Recall 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 · Initiated December 21, 2020

    Recall

    Recall Number
    Z-0922-2021
    Event Number
    87062
    Firm
    OMNIlife science Inc.
    FEI Number
    3008342029
    Product Code
    LZO
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 21, 2020
    Terminated
    June 10, 2021
    Address
    480 Paramount Dr, Raynham, MA, 02767-1085

    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

    Action

    Omni Life Initial communication was sent by email via a quarantine form on 12/09/2020. On 12/22/20 a notification packet detailing parameters of recall sent via email and overnight mail. Acknowledgement of receipt is requested. Actions to be taken by the Customer/User " Immediately quarantine lots 28413, 28624 and 28572 " Return Product to OMNI at 480 Paramount Drive, Raynham MA 02767 " This advisory notice only includes the lots identified above. It does not affect other lots. You must acknowledge this notice by returning the attached Acknowledgement and Receipt Form by FAX to 508-819-3390 or my email to [email protected].

    Distribution

    AL, ID, MD, NY, OK

    Quantity

    2 units