BEUDAMED
    FDA Recall Terminated

    Biomet Marrowstim Concentration Kit w/single Disposable Separator, Bone Marrow Needle, and 30 ml ACD-A. For use with BBI centrifuges only, sterile, Biomet Biologics, Warsaw, IN; REF 800-0611A and 800-0613A. The device is used for the rapid preparation of platelet-poor-plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow.

    Recall: Z-1207-2009 · Initiated March 5, 2009

    Recall

    Recall Number
    Z-1207-2009
    Event Number
    51316
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JQC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 5, 2009
    Posted
    April 17, 2009
    Terminated
    July 7, 2009
    Address
    56 E Bell Dr, Warsaw, IN, 46582

    Description

    Biomet Marrowstim Concentration Kit w/single Disposable Separator, Bone Marrow Needle, and 30 ml ACD-A. For use with BBI centrifuges only, sterile, Biomet Biologics, Warsaw, IN; REF 800-0611A and 800-0613A. The device is used for the rapid preparation of platelet-poor-plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow.

    Reason

    A 30 ml tube is packaged with the kit instead of the labeled 60 ml tube.

    Action

    Consignees were notified by "URGENT MEDICAL DEVICE REMOVAL NOTICE " dated March 5, 2009 and instructed to locate and return the recalled products. Direct questions about this recall to Biomet Orthopedics at 1-800-348-9500 or 574-372-3983, Monday through Friday, 8AM to 5PM.

    Distribution

    Worldwide Distribution -- USA including states of Massachusetts and Minnesota and countries of Germany and Italy.

    Quantity

    27 total kits of both products