BEUDAMED
    FDA Recall Terminated

    Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, Threaded in the following sizes: 75mm (Catalog Number: 50-1101), 100mm (Catalog Number: 50-1014), 150mm (Catalog Number: 50-1015) and 200mm (Catalog Number: 50-1016), distributed by Orthofix, Inc., McKinney, TX 75069.

    Recall: Z-0674-2008 · Initiated September 28, 2007

    Recall

    Recall Number
    Z-0674-2008
    Event Number
    45878
    Firm
    Orthofix, Inc
    FEI Number
    2183449
    Product Code
    LXT
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 28, 2007
    Posted
    February 26, 2008
    Terminated
    March 20, 2008
    Address
    1720 Bray Central Dr, Mckinney, TX, 75069-8207

    Description

    Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, Threaded in the following sizes: 75mm (Catalog Number: 50-1101), 100mm (Catalog Number: 50-1014), 150mm (Catalog Number: 50-1015) and 200mm (Catalog Number: 50-1016), distributed by Orthofix, Inc., McKinney, TX 75069.

    Reason

    Markings reversed: Graduated markings on telescoping bone distractors were reversed, causing the distractors to compress rather than distract the treatment site when adjusted.

    Action

    Orthofix notified sales agents by phone starting on 09/28/07. Sales agents were to return product for replacements.

    Distribution

    Nationwide Distribution - USA states: CA, FL, GA, IL, PA, MI, NY and WI.

    Quantity

    69 units.