BEUDAMED
    FDA Recall Terminated

    Foot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion.

    Recall: Z-1721-2009 · Initiated March 6, 2009

    Recall

    Recall Number
    Z-1721-2009
    Event Number
    51317
    Firm
    Med Tec Inc
    FEI Number
    1000143606
    Product Code
    IXQ
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    March 6, 2009
    Posted
    August 20, 2009
    Terminated
    November 5, 2009
    Address
    1401 8th St PO Box 320, Orange City, IA, 51041-0320

    Description

    Foot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion.

    Reason

    The silkscreened indexing scale was reversed.

    Action

    Med Tec inc. (CIVCO Medical Solutions, Radiation Oncology) issued a "Recall Notification" notice dated March 6, 2009 via certified mail explaining the reason for recall and providing the customer a choice of returning the product for replacement or not take any action. A response form was enclosed to be returned via FAX to indicate the number of units in their possession and whether or not they are being returned. Telephone calls were initiated April 20, 2009 to nonresponders or for any consignee whose letter was returned as undeliverable. Foreign customers were notified by e-mail or phone beginning March 16, 2009. For further information, contact CIVCO Medical Solutions, Radiation Oncology at 1-800-842-8688.

    Distribution

    Worldwide Distribution -- Including the United States, Czech Republic, Colombia, Thailand, Morocco, Brazil, the United Kingdom, India, Costa Rica, The Netherlands, Russia, Spain, Israel, Taiwan, Mexico, Turkey, Korea, Australia, Malaysia, Italy and Japan.

    Quantity

    231 units