BEUDAMED
    FDA Recall Terminated

    Reverse Shoulder Prosthesis (RSP) custom device component; RSP 40mm Poly Socket Assembly; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758.

    Recall: Z-1253-2007 · Initiated March 22, 2007

    Recall

    Recall Number
    Z-1253-2007
    Event Number
    37874
    FEI Number
    1000116912
    Product Code
    KWS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 22, 2007
    Posted
    September 25, 2007
    Terminated
    March 27, 2008
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

    Description

    Reverse Shoulder Prosthesis (RSP) custom device component; RSP 40mm Poly Socket Assembly; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758.

    Reason

    Marketed without approval: Investigational devices were implanted during an IDE study prior to receiving approval for the devices in the study; patients were implanted with investigational devices outside of the IDE study; and devices implanted as "custom devices" by the manufacturer did not meet the definition of "custom devices" and were, therefore, unapproved devices.

    Action

    Letters were sent via Certified Mail on 03/22/07 to the surgeons and their associated IRBs. Each letter included a list of the patients to be notified and a form letter that the surgeons could use to notify the patients. Surgeons asked to notify their patients and to provide Encore with documented evidence that patience were notified.

    Distribution

    Nationwide: Devices sold to and implanted by physicians in CA, CO, FL, GA, NY, SC and TX.

    Quantity

    20 units.