Recall Z-2793-2026
Alphatec Spine, Inc. · initiated May 13, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Codes / lots: UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230
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.
FDA-determined cause: Software Design 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.
Details
- Recall number
- Z-2793-2026
- Initiated
- May 13, 2026
- Posted by FDA
- July 23, 2026
- Product code
- GWF – Stimulator, Electrical, Evoked Response
- Quantity
- 3
- Distribution
- US Nationwide distribution in the states of TX, MO, IN.
- Recalling firm
- Alphatec Spine, Inc., Carlsbad, CA