BEUDAMED
    FDA Recall Terminated

    smith & nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma Launcher V1.01.1 Product is intended to be an intraoperative image-guided localization system. It is a computer-assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation.

    Recall: Z-0411-2011 · Initiated October 15, 2010

    Recall

    Recall Number
    Z-0411-2011
    Event Number
    57047
    Firm
    Smith & Nephew Inc
    FEI Number
    1020279
    Product Code
    OLO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 15, 2010
    Posted
    November 18, 2010
    Terminated
    February 17, 2011
    Address
    1450 E. Brooks Rd, Memphis, TN, 38116

    Description

    smith & nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma Launcher V1.01.1 Product is intended to be an intraoperative image-guided localization system. It is a computer-assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation.

    Reason

    Targeting software has been found to provide erroneous targeting when used with the 13 mm TAN/FAN Left nails.

    Action

    Smith & Nephew Inc. sent an URGENT MEDICAL DEVICE CORRECTION letter by FedEx on October 15, 2010, to all customers. The letter was dated October 4, 2010, and identified the product, the problem, and the action to be taken by the customers. Customers were instructed to perform a software upgrade and complete the form provided and return by fax to (901) 566-7835. For questions regarding this recall call (901) 399-5441.

    Distribution

    Worldwide Distribution - USA including AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NM, OH, PA, TN, TX, AND WA and the countries of Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, Turkey, and the UK.

    Quantity

    445 units