FDAFDA recall Z-2793-2026 · Jul 29, 2026
Alphatec Spine, Inc.: SafeOp Patient Interface recall
Recall found
Product
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Reason for recall
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 to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230
- Quantity
- 3
- Distribution
- US Nationwide distribution in the states of TX, MO, IN.
- Recalling firm
- Alphatec Spine, Inc., Carlsbad, CA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-13
Source: openFDA enforcement record Z-2793-2026 · search recall number Z-2793-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.