Alphatec Spine, Inc. recalls SafeOp Patient Interface
- Recalling company
- Alphatec Spine, Inc.
- Product
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- May 13, 2026
- Reported
- Jul 29, 2026
- Distribution
- US Nationwide distribution in the states of TX, MO, IN.
- Status
- Ongoing
- Quantity
- 3
- Lot / codes
- UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230
- Company location
- Carlsbad, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2793-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2793-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.