SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
FDA device recall Z-2793-2026 · posted 2026-07-23 · Open, Classified
Recall details
- 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.
- Action taken
- 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 QMSCompliance@atecspine.com or call 1-800-922-1356.
- Root cause
- Software Design Change
- Status
- Open, Classified
- Product code
- GWF
- Quantity affected
- 3
- Distribution
- US Nationwide distribution in the states of TX, MO, IN.
- Date initiated
- 2026-05-13
- Date posted
- 2026-07-23
- Location
- Carlsbad, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SafeOp 3: Neural Informatix System (K252842) | Alphatec Spine, Inc. | 2026-01-11 |