Reported Jul 26, 2017 · Terminated
Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
Medtronic Navigation, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Navigation, Inc. · 826 Coal Creek Cir · Louisville, CO · 80027-9710
Is this the product you have?
- Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
- Lot codes and dates
- Kits that
- include affected 9731958 INSTALL CD
INST SET 9734833 UNIVERSAL NAVLOCKINST SET 9734834 CAPSTONE TRIALSINST SET 9734835 CLYDESDALE TRIALSINST SET 9734836 TLIF/DLIF INSERTERINST SET 9735283 SOLERA 5.5/6.0 DRIVERSINST SET 9735284 SOLERA NONCAN TAPSINST SET 9735285 SOLERA ILIAC TAPSTAPS KIT 9735465 SOLERA AWL-TIP TAPSREF SET 9735500 SPINE REFRENCINGUPGRD KIT 9735522 SPINE REVISIONINSTR SET 9735607 VERTEX SELECT
- Amount recalled
- 108
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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