BEUDAMED
    FDA Enforcement Class II Terminated

    Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)

    Recall: Z-2064-2015 · Reported July 22, 2015

    Enforcement

    Recall Number
    Z-2064-2015
    Event ID
    71407
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Omnilife Science Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 22, 2015
    Initiation Date
    June 3, 2015
    Classification Date
    July 14, 2015
    Termination Date
    September 8, 2015
    Address
    50 Oconnell Way Ste 10, N/A, East Taunton, MA, 02718-1394, United States

    Description

    Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)

    Reason

    Product may breach the inner and outer sterile pouches during shipping or handling.

    Code Info

    Lot Numbers: 5679, 5777, 7420, 7588, 7787, 8369, 8605, 8869, 9485, 9688, 18070

    Distribution

    US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY.

    Quantity

    146 devices