BEUDAMED
    FDA Recall Terminated

    Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.

    Recall: Z-1352-2015 · Initiated February 24, 2015

    Recall

    Recall Number
    Z-1352-2015
    Event Number
    70579
    Firm
    Synthes, Inc.
    FEI Number
    3005180112
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    February 24, 2015
    Posted
    March 30, 2015
    Terminated
    September 21, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.

    Reason

    The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.

    Action

    DePuy Synthes sent an Urgent Notice: Medical Device Recall letter, dated March 2, 2015, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to review inventory for the affected parts and following the actions provided in the letter for removal and replacement of these devices. For questions call 610-719-5450.

    Distribution

    US Nationwide Distribution - NY, TX, MD, OR, MS, ND, CA, AZ, MI, IL, PA, TN, AR, SD, SC, FL, VA, OK, and GA

    Quantity

    131