BEUDAMED
    FDA Recall Terminated

    Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical

    Recall: Z-0798-2011 · Initiated November 5, 2010

    Recall

    Recall Number
    Z-0798-2011
    Event Number
    57210
    FEI Number
    1000116912
    Product Code
    KWS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 5, 2010
    Posted
    December 22, 2010
    Terminated
    April 5, 2011
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

    Description

    Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical

    Reason

    Complaints of fracturing were reported for trial products.

    Action

    Encore Medical notified consignees by letter on 11/5/2010.

    Distribution

    TX, FL, SC, GA

    Quantity

    425 units