Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
FDA device recall Z-2746-2017 · posted 2017-06-26 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc.
- 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.
- Action taken
- Medtronic sent an Urgent - Product Advisory Notice dated May 10, 2017, to all affected customers. Instructions indicated that a Medtronic representative will be in contact to update the system with version 26 and will remove any copies of the Spine Tools Install CD, version 25. Please quarantine any copies of version 25 until they can be removed. If you have further questions regarding this communication, please contact your local Medtronic Navigation Technical Services Representative, your local Medtronic Spine Sales Representative, or call (800 595-9709.
- Root cause
- Software in the Use Environment
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 108
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Brazil, Germany, Switzerland and Great Britain.
- Date initiated
- 2017-05-10
- Date posted
- 2017-06-26
- Date terminated
- 2021-01-08
- Location
- Louisville, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STEALTHSTATION SYSTEM UPDATE (K050438) | Medtronic Surgical Navigation Technologies | 2005-06-02 |