BEUDAMED
    FDA Recall Terminated

    Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 30 degrees, Zimmer, Warsaw, IN; REF 00-7806-035-02. The offset rasp handle is a surgical instrument used with various sizes of femoral rasps to prepare the femoral canal for a hip implant.

    Recall: Z-0991-2009 · Initiated December 19, 2008

    Recall

    Recall Number
    Z-0991-2009
    Event Number
    50552
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    December 19, 2008
    Posted
    February 27, 2009
    Terminated
    December 22, 2009
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 30 degrees, Zimmer, Warsaw, IN; REF 00-7806-035-02. The offset rasp handle is a surgical instrument used with various sizes of femoral rasps to prepare the femoral canal for a hip implant.

    Reason

    The c-clip located near the connection end may fracture or fall off during use in surgical procedures.

    Action

    U.S. consignees were notified by "Urgent: Device Recall" letter issued via e-mail on December 19, 2008. The letter described the problem and instructed customers to immediately quarantine and return the recalled product along with the completed Inventory Return Certification form to the Zimmer, Inc. Distribution Center. Consignees were also instructed to fax a copy of the completed Inventory Return Certification Form at 1-574-371-8603. International consignees were also notified, but Zimmer, Inc. will gather the instruments from those customers. Direct questions about the recall to Zimmer, Inc. at 1-800-613-6131.

    Distribution

    Worldwide Distribution --- including USA, Belgium, Czech Republic, Finland, Germany, Greece, Italy, Poland, Romania, Spain and United Kingdom.

    Quantity

    1,461 of both products.