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Terminated

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

FDA Recall Z-2746-2017 · Posted 2017-06-26

Recalling FirmMedtronic Navigation, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2017-05-10
Date Terminated2021-01-08
Product Quantity108

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.

Firm 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.

Root Cause

Software in the Use Environment

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050438STEALTHSTATION SYSTEM UPDATEMedtronic Surgical Navigation Technologies · 2005-06-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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