BEUDAMED
    FDA Recall Terminated

    Femoral Speed Block Size 8, Part/Catalog #800-01-368; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; distributed by Encore Medical, L.P., Austin, TX 78758.

    Recall: Z-1138-2007 · Initiated August 15, 2006

    Recall

    Recall Number
    Z-1138-2007
    Event Number
    37878
    FEI Number
    1000116912
    Product Code
    LKH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 15, 2006
    Posted
    August 7, 2007
    Terminated
    March 27, 2008
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

    Description

    Femoral Speed Block Size 8, Part/Catalog #800-01-368; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; distributed by Encore Medical, L.P., Austin, TX 78758.

    Reason

    Complaints received that device used to prepare femur to receive femoral implant would split during surgery.

    Action

    Firm sent notification letter to consignees on 08/25/2006, along with replacement speedblocks. Consignees asked to trade out old speedblocks with the replacements.

    Distribution

    Product distributed to direct accounts in USA and one consignee in Japan.

    Quantity

    24 units.