Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Kits that include affected 9731958 INSTALL CD: INST SET 9734833 UNIVERSAL NAVLOCK, INST SET 9734834 CAPSTONE TRIALS, INST SET 9734835 CLYDESDALE TRIALS, INST SET 9734836 TLIF/DLIF INSERTER, INST SET 9735283 SOLERA 5.5/6.0 DRIVERS, INST SET 9735284 SOLERA NONCAN TAPS, INST SET 9735285 SOLERA ILIAC TAPS, TAPS KIT 9735465 SOLERA AWL-TIP TAPS, REF SET 9735500 SPINE REFRENCING, UPGRD KIT 9735522 SPINE REVISION, INSTR SET 9735607 VERTEX SELECT
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
Product Codes/Lot Numbers:
Kits that include affected 9731958 INSTALL CD: INST SET 9734833 UNIVERSAL NAVLOCK, INST SET 9734834 CAPSTONE TRIALS, INST SET 9734835 CLYDESDALE TRIALS, INST SET 9734836 TLIF/DLIF INSERTER, INST SET 9735283 SOLERA 5.5/6.0 DRIVERS, INST SET 9735284 SOLERA NONCAN TAPS, INST SET 9735285 SOLERA ILIAC TAPS, TAPS KIT 9735465 SOLERA AWL-TIP TAPS, REF SET 9735500 SPINE REFRENCING, UPGRD KIT 9735522 SPINE REVISION, INSTR SET 9735607 VERTEX SELECT
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2746-2017
Related Recalls
Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.
Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.
Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.