BEUDAMED
    FDA Recall Terminated

    OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840

    Recall: Z-2481-2019 · Initiated July 23, 2019

    Recall

    Recall Number
    Z-2481-2019
    Event Number
    83528
    Firm
    OMNIlife science Inc.
    FEI Number
    3008342029
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 23, 2019
    Terminated
    April 24, 2020
    Address
    480 Paramount Dr, Raynham, MA, 02767-1085

    Description

    OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840

    Reason

    Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.

    Action

    OMNIlife science, Inc. sent an Urgent Medical Device Recall letter, dated July 23rd, 2019. 1. Identify the affected product from inventory and hold (quarantine) the product. 2. Return product to Omni at 480 paramount drive, Raynham, MA 02767 3. Acknowledge this notice by retuning the acknowledgement and receipt form by fax to 508-819-3390 or email to [email protected] For further information contact Christina Rovaldi, Regulatory Affairs Manager at 774-226-1847 or 800-448-6664. Return the attached Acknowledgement form by FAX to 508-819-3390 or by email to [email protected]. Company contact hours are Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time.

    Distribution

    US nationwide distribution to states of: IL, NY, OK, MD, AL, PA, CO, FL, and UT.

    Quantity

    6