BEUDAMED
    FDA Recall Terminated

    ALFA II Modular Femoral Left Modular Stem Porous Coated (Bowed); Size 6 Left; Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180L; component of the ENCORE Hip System; Single Use, Sterile; distributed by Encore Medical, L.P., Austin, TX 78758.

    Recall: Z-1065-2007 · Initiated April 12, 2007

    Recall

    Recall Number
    Z-1065-2007
    Event Number
    37881
    FEI Number
    1000116912
    Product Code
    JDI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 12, 2007
    Posted
    July 23, 2007
    Terminated
    July 25, 2007
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

    Description

    ALFA II Modular Femoral Left Modular Stem Porous Coated (Bowed); Size 6 Left; Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180L; component of the ENCORE Hip System; Single Use, Sterile; distributed by Encore Medical, L.P., Austin, TX 78758.

    Reason

    Sterility/Package Integrity: Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions.

    Action

    Urgent Device Recall Notification letters distributed to consignees on 04/14/07. Consignees requested to return product to Encore Medical, L.P.

    Distribution

    Product distributed to surgical centers in CT, KS and MO.

    Quantity

    2 units.