BEUDAMED
    FDA Recall Terminated

    Suture Lariat 45 Degree Dog Leg Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904025. Used to pass suture through tissue.

    Recall: Z-2232-2010 · Initiated June 18, 2010

    Recall

    Recall Number
    Z-2232-2010
    Event Number
    56193
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    MDM
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    June 18, 2010
    Posted
    August 16, 2010
    Terminated
    August 6, 2012
    Address
    56 E Bell Dr, Warsaw, IN, 46582

    Description

    Suture Lariat 45 Degree Dog Leg Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904025. Used to pass suture through tissue.

    Reason

    The nitinol wire may be fractured or may have the potential to fracture making the suture lariat unusable and possibly delaying surgery.

    Action

    The firm notified all 29 consignees by An Urgent Medical Device Recall Notice letter on 6/18/2010. The letter identified the affected product and explained the reason for recall. Customers are asked to locate and remove the affected products, follow the instructions on the enclosed "FAX Back Response Form," and fax a copy of the form back prior to return of the affected product. Additionally, if product has been further distributed, then hospital personnel must be notified and given the "Dear Biomet Customer" letter. Questions should be directed to Mary Johnson at 800-348-9500 or 574-372-3983.

    Distribution

    Worldwide Distribution -- USA, including the states of FL, IL, NY, CO, MD, CA, GA, AL, PA, OH, SD, KY, TX, ID, WA, NC, AK, & MN, and Columbia and The Netherlands.

    Quantity

    301 units total