Reported Jul 29, 2026 · Ongoing · Updated Sep 16, 2026
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Alphatec Spine, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alphatec Spine, Inc. · 1950 Camino Vida Roble · Carlsbad, CA · 92008-6505
Is this the product you have?
- SafeOp Patient Interface
- REFAIX11240
- part of SafeOp 3Neural Informatix System
- Lot codes and dates
- UDI-DI00190376517506. System
- Set ID/Patient Interface Serial Number
2007716/ DG1062252005498/ DG1062202005490/ DG106230
- Amount recalled
- 3
Where it was sold
Why it was recalled
Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change.
This product could cause temporary or reversible health problems — stop using it.
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