Medtronic Navigation, Inc. recalls Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.

Recall date

May 10, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2746-2017

FDA classification

Class II

Brand / firm

Medtronic Navigation, Inc.

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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