Company:Medtronic Navigation Inc.
Date of Enforcement Report 7/26/2017
Class lI:
PRODUCT
Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
Recall Number Z-2746-2017
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..
RECALLING FIRM/MANUFACTURER
Medtronic Navigation Inc, Louisville, COon 5/10/2017. Voluntary: Firm Initiated recall is ongling.
VOLUME OF PRODUCT IN COMMERCE
108
DISTRIBUTION
Worldwide Distribution – USA (nationwide) Distribution and to the countries of : Brazil, Germany, Switzerland and Great Britain.
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