Z-2793-2026 Class II Ongoing
FDA device recall Z-2793-2026 was initiated by Alphatec Spine, Inc. on May 13, 2026 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 3.
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2026
- Initiation Date
- May 13, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
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.
Distribution Pattern
US Nationwide distribution in the states of TX, MO, IN.
Code Information
UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230