Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
Reported: July 26, 2017 Initiated: May 10, 2017 #Z-2746-2017
Product Description
Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
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.
Details
- Recalling Firm
- Medtronic Navigation, Inc.
- Units Affected
- 108
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Brazil, Germany, Switzerland and Great Britain.
- Location
- Louisville, CO
Frequently Asked Questions
What product was recalled? ▼
Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.. Recalled by Medtronic Navigation, Inc.. Units affected: 108.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 26, 2017. Severity: Moderate. Recall number: Z-2746-2017.
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