Recall Z-2793-2026— Alphatec Spine, Inc.
Class II · Ongoing
Class II FDA medical device recall by Alphatec Spine, Inc., initiated 2026-05-13. It names one FDA 510(k) clearance: K252842. 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..
- Recalling firm
- Alphatec Spine, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-05-13
- Firm location
- Carlsbad, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.