BEUDAMED
    FDA Recall Terminated

    Artificial ligament fixation device # 7PE ZIPLOOP Extended Toggle, Sterile, REF 904755, Biomet Sports Medicine Warsaw, IN. Intended for soft tissue to bone fixation.

    Recall: Z-1952-2010 · Initiated March 31, 2010

    Recall

    Recall Number
    Z-1952-2010
    Event Number
    55776
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    MBI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 31, 2010
    Posted
    July 1, 2010
    Terminated
    August 6, 2012
    Address
    56 E Bell Dr, Warsaw, IN, 46582

    Description

    Artificial ligament fixation device # 7PE ZIPLOOP Extended Toggle, Sterile, REF 904755, Biomet Sports Medicine Warsaw, IN. Intended for soft tissue to bone fixation.

    Reason

    The firm has received complaints that the saddle is too long. The saddle is supposed to be between 7/8 and 1 1/8 inches long. The saddle in the complaints was up to 1.9 inches long.

    Action

    Biomet Sports Medicine issued an "Urgent Medical Device Recall Notice" dated March 31, 2010 to user facilities and distributors. A second notification containing updated information was issued June 2, 2010. Consignees were instructed to discontinue use of the product and return it to the firm along with a completed Response Form. For further information, contact Biomet at 1-574-371-3755 or 1-574-371-3756, Monday through Friday, 8AM to 5PM.

    Distribution

    Worldwide Distribution -- United States, Canada, Australia, The Netherlands, Belgium, Italy, France, New Zealand, Austria, United Kingdom, Chile, Greece, Poland, Denmark, Turkey, Portugal, South Africa and Spain.

    Quantity

    2466 both products