BEUDAMED
    FDA Recall Terminated

    Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150). ZIMMER Compression Hip Screw , orthopedic implant.

    Recall: Z-2091-2013 · Initiated June 19, 2013

    Recall

    Recall Number
    Z-2091-2013
    Event Number
    65513
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    KTT
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    June 19, 2013
    Posted
    August 26, 2013
    Terminated
    June 16, 2015
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150). ZIMMER Compression Hip Screw , orthopedic implant.

    Reason

    Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.

    Action

    The firm, Zimmer, sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated July 11, 2013 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to inspect the device according to the insert instructions; not use the device if damage to the corner of the inner tray is observed, and contact the firm for return and questions. Customers should also keep this notification in mind and inform Zimmer of product with this condition using [email protected]. If after reviewing this notification you have questions or concerns, please contact Zimmer at 1-877-946-2761.

    Distribution

    Worldwide distribution: US Nationwide (including PR and USVI), and countries of: Israel, Argentina, Brazil, France, Mexico, Saudi Arabia, Beirut, China, Korea, San Salvador, Honduras, Canada, Australia, Switzerland, Germany, Arab Emirates, UK, Belgium, Egypt, Spain, France, Italy, Iran, Lebanon, Jordan, Iraq, Canary Islands.

    Quantity

    85, 794 units in total