SafeOp Patient Interface recall (Alphatec Spine, Inc.)
Medical deviceClass IIOngoing
Summary: Alphatec Spine, Inc. is recalling SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System. Reason: 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.
What is being recalled
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of TX, MO, IN. (states named: Indiana, Missouri, Texas)
How to tell if yours is affected
UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2793-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 13, 2026 |
| Reported | July 29, 2026 |
| Company | Alphatec Spine, Inc. |
| Company location | Carlsbad, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 3 |
More recalls from Alphatec Spine, Inc. · all medical device recalls · recalls from May 2026