FDAFDA · Food and drugs·Recall number Z-2793-2026
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Published July 29, 2026 · Recall initiated: May 13, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
Voluntary: Firm initiated
Recall details
- Manufacturer
- Alphatec Spine, Inc.
- Distributor
- US Nationwide distribution in the states of TX, MO, IN.
- Lot
- UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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