BEUDAMED
    FDA Recall Terminated

    TM-300 Traction System; an Rx software driven device used for patient traction; Manufactured for Sammons Preston Roylan, An Ability One Company, Bolingbrook, IL 60440, Manufactured by: ITO Co., Ltd., 3-3-3 Toyotama-Minami, Nerima-ku, Tokyo, 176-8605, Japan

    Recall: Z-1444-05 · Initiated July 13, 2005

    Recall

    Recall Number
    Z-1444-05
    Event Number
    31492
    Firm
    Sammons Preston Rolyan, An Ability One Company
    FEI Number
    1418324
    Product Code
    HST
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 13, 2005
    Posted
    August 31, 2005
    Terminated
    January 9, 2008
    Address
    4 Sammons Ct, Bolingbrook, IL, 60440-4995

    Description

    TM-300 Traction System; an Rx software driven device used for patient traction; Manufactured for Sammons Preston Roylan, An Ability One Company, Bolingbrook, IL 60440, Manufactured by: ITO Co., Ltd., 3-3-3 Toyotama-Minami, Nerima-ku, Tokyo, 176-8605, Japan

    Reason

    The traction device may malfunction, producing oscillation and a jerking motion.

    Action

    Sammons Preston Roylan, the U.S. agent for Ito Co., Ltd. issued recall letters dated 7/13/05 to all of their customers who purchased the Performa TM-300 traction unit, informing them that the manufacturer, Ito Co., Ltd., is recalling the units because the units may exhibit oscillation during some traction modes. The accounts were requested to contact Tina Kreisher at 1-800-323-5547, ext. 1383 if their TM-300 unit has a serial number that falls in the range listed in the recall letter. Tina will arrange for the unit to be shipped to the manufacturer's authorized repair center for upgrading of the software to version 2.8, and for the shipment of a loaner unit while their unit is being upgraded.

    Distribution

    Nationwide and internationally to Canada, the United Kingdom, Korea, Turkey and Indonesia

    Quantity

    208 units