FDA recall Z-2746-2017

Medtronic Navigation, Inc. · Class II · device

Product

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.

Distribution

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

Key facts

Status: Terminated
Initiation date: 2017-05-10
Report date: 2017-07-26
Termination date: 2021-01-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Louisville, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2746-2017