BEUDAMED
    FDA Recall Terminated

    Foundation Hip System Bipolar Modular, Size 46mm OD; Cat. #412-01-046; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.

    Recall: Z-0088-2008 · Initiated August 2, 2007

    Recall

    Recall Number
    Z-0088-2008
    Event Number
    44788
    FEI Number
    1000116912
    Product Code
    KWY
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    August 2, 2007
    Posted
    November 7, 2007
    Terminated
    January 9, 2008
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

    Description

    Foundation Hip System Bipolar Modular, Size 46mm OD; Cat. #412-01-046; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.

    Reason

    Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.

    Action

    Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.

    Distribution

    Worldwide, including USA, Greece, Japan, and Saudi Arabia.

    Quantity

    605 units.