BEUDAMED
    FDA Recall Terminated

    Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, TX 78758 STERILE R Model numbers: 508-00-000 and 508-00-008. The Reverse Shoulder Prosthesis (RSP) is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant (s), and a functional deltoid muscles in necessary to use the device.

    Recall: Z-2739-2011 · Initiated April 18, 2011

    Recall

    Recall Number
    Z-2739-2011
    Event Number
    58562
    FEI Number
    1000116912
    Product Code
    KWS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 18, 2011
    Posted
    July 6, 2011
    Terminated
    January 25, 2012
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

    Description

    Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, TX 78758 STERILE R Model numbers: 508-00-000 and 508-00-008. The Reverse Shoulder Prosthesis (RSP) is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant (s), and a functional deltoid muscles in necessary to use the device.

    Reason

    The device has the potential to not appropriately mate with the humeral stem.

    Action

    DJO Surgical sent an "URGENT FIELD SAFETY NOTICE" letter dated April 18, 2011 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers. The letter instructed customers to quarantine affected products and to contact Customer Service to obtain replacement products and a RMA. Questions are directed to the Director of Commercial Logistics at 512-834-6330.

    Distribution

    Worldwide Distribution--USA (nationwide) including the states of CA, FL, IL, LA, MA, MD, ME, NM, NY, OK, PA, SC, TN, TX, UT, and WA and the countries of Germany, Italy, and United Kingdom.

    Quantity

    81 units