Z-2746-2017Class II

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

Name: Z-2746-2017 Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958
Creator: Medtronic Navigation, Inc.
Published: 2017-05-10
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2017-05-10 / Terminated / root cause: software

FDA source

Medtronic Navigation, Inc. began a recall of Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958 on 2017-05-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2746-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-10
Posted: 2017-06-26
Terminated: 2021-01-08
Recalling firm: Medtronic Navigation, Inc
Product: Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software in the Use Environment
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.
Quantity in commerce: 108
Distribution: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Brazil, Germany, Switzerland and Great Britain.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2746-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2746-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-26	2017-07-19

Product code HAW

K050438Class IIStealthstation System UpdateMedtronic Surgical Navigation Technologies / cleared 2005-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)