BEUDAMED
    FDA Recall Terminated

    Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.

    Recall: Z-2746-2017 · Initiated May 10, 2017

    Recall

    Recall Number
    Z-2746-2017
    Event Number
    77354
    Firm
    Medtronic Navigation, Inc.
    FEI Number
    1000517638
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Software in the Use Environment
    Initiated
    May 10, 2017
    Posted
    June 26, 2017
    Terminated
    January 8, 2021
    Address
    826 Coal Creek Cir, Louisville, CO, 80027-9710

    Description

    Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.

    Reason

    Software issue related to the StealthStation S7 system and the Synergy Spine application Version 2.1 configured with Spine Tool Install CD version 25. Issue may result in user being unable to navigate the Navigated Elevate Inserter with the StealthAiR Spine Frame during spine surgical procedures.

    Action

    Medtronic sent an Urgent - Product Advisory Notice dated May 10, 2017, to all affected customers. Instructions indicated that a Medtronic representative will be in contact to update the system with version 26 and will remove any copies of the Spine Tools Install CD, version 25. Please quarantine any copies of version 25 until they can be removed. If you have further questions regarding this communication, please contact your local Medtronic Navigation Technical Services Representative, your local Medtronic Spine Sales Representative, or call (800 595-9709.

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Brazil, Germany, Switzerland and Great Britain.

    Quantity

    108