BEUDAMED
    FDA Recall Terminated

    Apex Hip System Bipolar Head, 22.225mm ID, 41 mm OD Product Code: H3-82241. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.

    Recall: Z-1969-2009 · Initiated July 10, 2009

    Recall

    Recall Number
    Z-1969-2009
    Event Number
    52662
    Firm
    Omni Life Science
    FEI Number
    3008342029
    Product Code
    KWY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 10, 2009
    Posted
    September 10, 2009
    Terminated
    June 28, 2012
    Address
    175 Paramont Drive, Raynham, MA, 02767

    Description

    Apex Hip System Bipolar Head, 22.225mm ID, 41 mm OD Product Code: H3-82241. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.

    Reason

    The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.

    Action

    Omni Life Science notified distributors and implanting surgeons by an Urgent, APEX Hip System Bipolar Head Voluntary Recall letter dated June 29, 2009. The method of notification is both e-mail and FedEx overnight. The letter requires a signature acknowledging receiving the letter and the letter is to be faxed back to Omni Life Science. The Distributors/Sale Representatives are instructed to fill in the "Quantity Returned" on the recall letter and fax back to Omni. They are to ship all existing Apex Hip System Bipolar Head inventory by 07/10/2009 to the directed address.

    Distribution

    Nationwide Distribution -- Including states of AZ, CA, CO, FL, IL, MI, NJ, OK, UT, VA, and WI.

    Quantity

    18 units