Jul

2017

Spine tools Cl II Medtronic Navigation Install CD

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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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Spine tools Cl II Medtronic Navigation Install CD

Amy Sellers

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