BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2746-2017 · Reported July 26, 2017

    Enforcement

    Recall Number
    Z-2746-2017
    Event ID
    77354
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Navigation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 26, 2017
    Initiation Date
    May 10, 2017
    Classification Date
    July 19, 2017
    Termination Date
    January 8, 2021
    Address
    826 Coal Creek Cir, N/A, Louisville, CO, 80027-9710, United States

    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.

    Code Info

    Kits that include affected 9731958 INSTALL CD: INST SET 9734833 UNIVERSAL NAVLOCK, INST SET 9734834 CAPSTONE TRIALS, INST SET 9734835 CLYDESDALE TRIALS, INST SET 9734836 TLIF/DLIF INSERTER, INST SET 9735283 SOLERA 5.5/6.0 DRIVERS, INST SET 9735284 SOLERA NONCAN TAPS, INST SET 9735285 SOLERA ILIAC TAPS, TAPS KIT 9735465 SOLERA AWL-TIP TAPS, REF SET 9735500 SPINE REFRENCING, UPGRD KIT 9735522 SPINE REVISION, INSTR SET 9735607 VERTEX SELECT

    Distribution

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

    Quantity

    108