Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-2746-2017

May 10, 2017

Class II

Product summary

Firm
Medtronic Navigation, Inc.
Event
Event 77354
Status
Terminated
Classification
Class II
Quantity
108
Official record key
device-enforcement:Z-2746-2017

Official wording

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

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software issue