BEUDAMED
    FDA Recall Terminated

    Zimmer ITST" INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION LOCKING BOLT EXTRACTOR - NONSTERILE Zimmer, Warsaw, IN 46580, U.S.A. The ITST Intertrochanteric/Subtrochanteric Fixation Locking Bolt Extractor instrument is a reusable surgical instrument used to separate the femoral nail from the locking bolt after nail implantation/fixation in trauma surgeries

    Recall: Z-2289-2010 · Initiated July 5, 2010

    Recall

    Recall Number
    Z-2289-2010
    Event Number
    56328
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 5, 2010
    Posted
    August 26, 2010
    Terminated
    February 25, 2011
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    Zimmer ITST" INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION LOCKING BOLT EXTRACTOR - NONSTERILE Zimmer, Warsaw, IN 46580, U.S.A. The ITST Intertrochanteric/Subtrochanteric Fixation Locking Bolt Extractor instrument is a reusable surgical instrument used to separate the femoral nail from the locking bolt after nail implantation/fixation in trauma surgeries

    Reason

    Instruments were manufactured with the incorrect grade of steel, increasing the potential for fracture during use.

    Action

    Zimmer sent "Urgent: Device Removal" letters dated July 8, 2010 to consignees identifying the potential for fracture of the device. Consignees were instructed to inventory affected product and record on the Inventory Return Certification Form, to document users of the affected device on the User Facility/HCP Form, and return both forms by fax or email. Affected product is to be returned to Zimmer with a copy of the Inventory Return Certification Form. Returned product will be destroyed. Each of the affected consignees will be provided with a new instrument, manufactured with the correct 17-4 stainless steel. Consignees can contact Zimmer at 800-613-6131 or 574-372-4463

    Distribution

    Worldwide Distribution in the countries of US, Canada, Spain, Germany, and Great Britain.

    Quantity

    20 individual units