BEUDAMED
    FDA Recall Terminated

    Glenoid Head Inserter (RSP Inserter/Impactor), Device Part #804-03-041, All Lots. Product is a Shoulder Instrument used to place the Glenoid Head Trial onto the Baseplate

    Recall: Z-2636-2010 · Initiated July 12, 2010

    Recall

    Recall Number
    Z-2636-2010
    Event Number
    56220
    FEI Number
    1000116912
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 12, 2010
    Posted
    September 30, 2010
    Terminated
    June 30, 2011
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

    Description

    Glenoid Head Inserter (RSP Inserter/Impactor), Device Part #804-03-041, All Lots. Product is a Shoulder Instrument used to place the Glenoid Head Trial onto the Baseplate

    Reason

    Complaints indicate product's distal threaded tip may fracture under certain circumstances.

    Action

    DJO Surgical sent an "Urgent Field Safety Notice" Letter dated July 12, 2010, to all of their consignees. The letter described the product, the problem, and the action consignees should take. Consignees were instructed to: Contact their Customer Service Representative for an R-RPR (RMS) number and return all RSP Glenoid Head Inserters, 804-03-041, under the assigned number to receive credit. Complete and return the Field Safety Notice Response to the firm. Identify and inform any customers who were sold or received the product of the Field Safety Notice Any questions consignees should call the firm at (512) 834-6330.

    Distribution

    Worldwide Distribution - USA, including the states of AR, AZ, CA, FL, GA, ID, IL, IN, LA, MA, ME, MI, MO, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, and WI; and the countries of Puerto Rico, Germany, and Saudi Arabia.

    Quantity

    104