BEUDAMED
    FDA Recall Terminated

    Trauma Fixation Systems - The Slotted Mallet is an auxiliary optional instrument available with the Phoenix Tibia Nail System. If desired, it may be used to seat the nail into the medullary canal. The Phoenix Tibial Nail System is indicated for alignment, stabilization, fixation of fractures caused by trauma or disease and the fixation of long bones that have been surgically prepared for correction of deformity and arthrodesis.

    Recall: Z-2012-2008 · Initiated May 7, 2008

    Recall

    Recall Number
    Z-2012-2008
    Event Number
    48158
    FEI Number
    2242816
    Product Code
    FZY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 7, 2008
    Posted
    September 16, 2008
    Terminated
    October 22, 2008
    Address
    EBI, L.P. 100 Interpace Pkwy, Parsippany, NJ, 07054-1149

    Description

    Trauma Fixation Systems - The Slotted Mallet is an auxiliary optional instrument available with the Phoenix Tibia Nail System. If desired, it may be used to seat the nail into the medullary canal. The Phoenix Tibial Nail System is indicated for alignment, stabilization, fixation of fractures caused by trauma or disease and the fixation of long bones that have been surgically prepared for correction of deformity and arthrodesis.

    Reason

    Customer complaint received regarding the separation of the mallet handle during a medical procedure.

    Action

    Recall letters were sent to Sales reps and distributors on May 7, 2007. Questions should be directed to William Hennig, QA Manager at 973-299-9300.

    Distribution

    Product was distributed to 20 Biomet sales representatives and distributors nationwide.

    Quantity

    38 mallets