SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3:… recallZ-2793-2026 · Alphatec Spine, Inc. · initiated May 13, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Alphatec Spine, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Software Design Change
What the company is doing
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 [email protected] or call 1-800-922-1356.
Recall details
- Recall number
- Z-2793-2026
- Status
- Open, Classified
- Initiated by the company
- May 13, 2026
- Posted by the FDA
- Jul 23, 2026
- Recalling firm
- Alphatec Spine, Inc.
- Quantity
- 3
- Product code
- GWF
- FDA submissions
- K252842
- Distribution
- US Nationwide distribution in the states of TX, MO, IN.
Product description
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Code information (models, lots, serial numbers)
UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SafeOp 3 AIX11240Alphatec Spine, Inc. · Stimulator, electrical, evoked response1 recall8 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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