- Recalling firm
- Alphatec Spine, Inc.
- 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.
- Affected products (lot / model / serial)
- UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230
- Units affected
- 3
- Distribution pattern
- US Nationwide distribution in the states of TX, MO, IN.
- Firm location
- Carlsbad, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- N/A
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2793-2026
- Recall initiated
- May 13, 2026
- FDA classification date
- July 23, 2026
- FDA report date
- July 29, 2026
- FDA event ID
- 98967
- Last updated on HTM Vibe
- August 4, 2026