SafeOp Patient Interface
The device may experience loss or interruption of triggered electromyography functionality during use.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Alphatec Spine, Inc., of Carlsbad, California, began a recall of the SafeOp Patient Interface, REF AIX11240, part of the SafeOp 3: Neural Informatix System, on May 13, 2026. The FDA added the recall to its Enforcement Report on July 23, 2026.
The intraoperative neuromonitoring device may, due to a software issue, 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, which may result in increased operative time and surgical plan change.
The device was distributed nationwide in the states of Texas, Missouri, and Indiana.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
- UDI-DI
- 00190376517506
Details
- Company began the recall
- Event ID
- 98967
- Recall No.
- Z-2793-2026
- Company
- Alphatec Spine, Inc.Carlsbad, California
- Hazard
- Software defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
