Recall Z-2793-2026
- Recall number
- Z-2793-2026
- Event number
- 98967
- Firm
- Alphatec Spine, Inc.
- Firm FEI
- 2027467
- Product code
- GWF
- Status
- Open, Classified
- Initiated
- 2026-05-13
- Posted
- 2026-07-23
- Root cause
- Software Design Change
- 510(k) numbers
- K252842, K002969, K811848, K032741, K132616, K870567, K110140, K230415, K061639, K863175, K912685, K991899, K992911, K842543, K071821, K001101, K931428, K091940, K094054, K061645, K912775, K952294, K050798, K010087, K000963, K960170, K926516, K884870, K233292, K130403
Product#
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.