Recall Z-2746-2017— Medtronic Navigation, Inc.

Name: FDA recall Z-2746-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-10

Class II · Terminated

Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2017-05-10, terminated 2021-01-08. It names one FDA 510(k) clearance: K050438. Product: Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.. 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: Medtronic Navigation, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-05-10
Terminated: 2021-01-08
Firm location: Louisville, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K050438 — STEALTHSTATION SYSTEM UPDATEMedtronic Surgical Navigation Technologies·cleared 2005-06-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.