Recall Z-2793-2026 ยท GWF Stimulator, Electrical, Evoked Response
Alphatec Spine, Inc.
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
| Date | Jul 23, 2026 (initiated May 13, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Software Design Change |
| Action | On 5/13/2026, recall notices were emailed to customers who were advised of the following: 1) Recalling firm has provided replacement SafeOp 3 Systems. 2) Abstain from using affected devices and return to recalling firm. 3) Share this notice within your organization or any organization where the affected device(s) has(have) been transferred. 4) Fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions, as described in this notification. If you have any questions/concerns or require assistance with the recall, please e-mail QMSCo |
| Quantity | 3 |
| Distribution | US Nationwide distribution in the states of TX, MO, IN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K252842 | SafeOp 3: Neural Informatix System Alphatec Spine, Inc., Jan 11, 2026 |