BEUDAMED
    FDA Enforcement Class II 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 · Reported September 11, 2019

    Enforcement

    Recall Number
    Z-2481-2019
    Event ID
    83528
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    OMNIlife science Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 11, 2019
    Initiation Date
    July 23, 2019
    Classification Date
    September 5, 2019
    Termination Date
    April 24, 2020
    Address
    480 Paramount Dr, N/A, Raynham, MA, 02767-1085, United States

    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.

    Code Info

    LOT # 31707

    Distribution

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

    Quantity

    6