BEUDAMED
    FDA Recall Terminated

    Fiducial Markers (2mm spheres) Bone gold markers, Medical charged-particle radiation therapy system; Part Number: MT-NW-887-805, CIVCO Medical Solutions (MEDTEC), Orange City, IA 51041.

    Recall: Z-1613-2008 · Initiated February 28, 2008

    Recall

    Recall Number
    Z-1613-2008
    Event Number
    46905
    Firm
    Med Tec Inc dba CIVCO Medical Solutions
    FEI Number
    1000143606
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    February 28, 2008
    Posted
    May 21, 2008
    Terminated
    July 2, 2008
    Address
    1401 8th St PO Box 320, Orange City, IA, 51041-0320

    Description

    Fiducial Markers (2mm spheres) Bone gold markers, Medical charged-particle radiation therapy system; Part Number: MT-NW-887-805, CIVCO Medical Solutions (MEDTEC), Orange City, IA 51041.

    Reason

    Mislabeled: Fiducial markers were incorrectly labeled. They are marked (2mm spheres) Bone gold markers, but contain (0.9x3mm cylindrical) Soft tissue gold markers.

    Action

    Consignees were notified via telephone beginning 2/28/08 and a Recall Notification letter sent on 2/29/08. Users were requested to return any affected products for a replacement. They were also requested to return a recall notification form indicating the amount of affected product in their inventory. For additional information, call 800-842-8688.

    Distribution

    Nationwide Distribution including states of WA, PA, DE, AL, CT, WI, FL, TX, MN, and IL.

    Quantity

    36/3-marker pouches