BEUDAMED
    FDA Recall Terminated

    Exogen 4000+ Ultrasound Bone Healing System, SAFHS, Part Numbers 71034100 and 71034101, Rx only, Smith & Nephew, 1450 Brooks Road, Memphis TX 38116. The device is used for the non-invasive treatment of established nonunions excluding skull and vertebra.

    Recall: Z-1695-2009 · Initiated June 5, 2009

    Recall

    Recall Number
    Z-1695-2009
    Event Number
    52228
    Firm
    Smith & Nephew Inc
    FEI Number
    1020279
    Product Code
    LPQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 5, 2009
    Posted
    August 4, 2009
    Terminated
    November 18, 2010
    Address
    1450 E. Brooks Rd, Memphis, TN, 38116

    Description

    Exogen 4000+ Ultrasound Bone Healing System, SAFHS, Part Numbers 71034100 and 71034101, Rx only, Smith & Nephew, 1450 Brooks Road, Memphis TX 38116. The device is used for the non-invasive treatment of established nonunions excluding skull and vertebra.

    Reason

    Problems with transducer may result in a reduced ultrasound output.

    Action

    All affected Smith & Nephew consignees and distributors were notified of problem and the recall by letters (dated June 5, 2009 and June 8, 2009) via US mail. Patients were directed to return the instruments; physicians were informed that their patients were being contacted; and distributors were requested to return their stock and to notify anyone to whom the product was distributed to also return the product. Direct questions to Smith & Nephew, Inc. by calling at 1-800-836-4080.

    Distribution

    Worldwide Distribution -- US, Switzerland, Canada, Malaysia, Japan, and UK.

    Quantity

    4139 units