BEUDAMED
    FDA Recall Terminated

    ZMR Over the Junction Instruments for Revision, utilized for the following ZMR devices: Porous Stem,Nitrited Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Splined Straight Stem, Taper Stem and Bodies, Calcar Bodies, and Spout Bodies. Product Usage: The ZMR Hip Prosthesis is indicated for cementless total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur.

    Recall: Z-0324-2012 · Initiated October 21, 2011

    Recall

    Recall Number
    Z-0324-2012
    Event Number
    59814
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    October 21, 2011
    Posted
    December 1, 2011
    Terminated
    August 29, 2013
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    ZMR Over the Junction Instruments for Revision, utilized for the following ZMR devices: Porous Stem,Nitrited Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Splined Straight Stem, Taper Stem and Bodies, Calcar Bodies, and Spout Bodies. Product Usage: The ZMR Hip Prosthesis is indicated for cementless total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur.

    Reason

    This recall was initiated because it may not be clear to the surgeon whether the device can be used based on the instructions for use.

    Action

    The firm Zimmer, sent an "URGENT DEVICE CORRECTION" letter dated August 26, 2011 to Marketing Personnel, Distributors, Sales Representatives, Distribution Operation Managers, and Surgeons. The letters identified the reason for the recall, the product, and required actions to be taken. The letter also included Medwatch reporting information and a Certificate of Acknowledgement form to fax back to the recalling firm to confirm receipt of the recall notice. For questions contact Zimmer at 1-877-946-2761.

    Distribution

    Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Dubai/UAE, Eschbach, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Jordan, Israel, Korea, Lebanon, Mexico, Netherlands, New Zealand, Peru, Poland, Portugal, Russia, S. Africa, Saudi Arabia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, and Venezuela,

    Quantity

    119,284 total devices