Install CD — Class II medical device recall Z-2746-2017
Terminated recall by Medtronic Navigation, Inc., reported 2017-07-26, distributed nationwide. Software issue related to the StealthStation S7 system and the Synergy Spine application Version 2.1 configure
| Recall number | Z-2746-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2017-05-10 |
| Classified | 2017-07-19 |
| Reported by FDA | 2017-07-26 |
| Terminated | 2021-01-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CH, DE, GB |
| Quantity | 108 |
| Reason classes | software |
| Model numbers | 9731958, 9735500 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2746-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.