BEUDAMED
    FDA Recall Terminated

    Encore Reverse Shoulder Prosthesis (RSP), manufactured and distributed by Encore Medical, L.P. 9800 Metric Blvd., Austin, Texas 78758

    Recall: Z-1566-05 · Initiated July 28, 2005

    Recall

    Recall Number
    Z-1566-05
    Event Number
    32909
    FEI Number
    1000116912
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 28, 2005
    Posted
    September 21, 2005
    Terminated
    April 19, 2007
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

    Description

    Encore Reverse Shoulder Prosthesis (RSP), manufactured and distributed by Encore Medical, L.P. 9800 Metric Blvd., Austin, Texas 78758

    Reason

    Incorrect alignment markings or no markings at all on a reverse shoulder prosthesis unit.

    Action

    Recall was initiated by letter to sales agents on 07/28/2005.

    Quantity

    93 primary units and 56 revision units