Class II U.S. Food and Drug Administration

Alphatec Spine, Inc. SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural recall: Intraoperative neuromonitoring device, due to a software issue

Recall published 3 months ago

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.

The hazard: Device malfunction

A malfunction was identified in this device. What matters most is whether your particular unit falls inside the affected model, lot or serial range.

What the notice says: 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.

Why it matters: The device may not perform as intended — a mechanical failure, a software defect, an inaccurate reading, or an alarm that does not sound. For a device someone depends on, the consequence of the failure is usually worse than the failure itself.

Symptoms and when to call a doctor

If the device supports a vital function, do not disable or remove it on your own judgement. Contact the clinician who prescribed or fitted it, and use the back-up arrangement they gave you. Go to an emergency department if the symptoms the device is meant to manage are getting worse, or if an implanted device gives an unexpected alarm or shock.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2793-2026
Published
July 29, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Alphatec Spine, Inc.
Product type
Medical devices
Units affected
3
Distribution
Nationwide
Made in
United States
Lot / code info
UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230

Products covered by this recall

SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System

Check your product

The notice names 6 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Model or item number

On the rating label, the box or the instruction sheet.

  • AIX11240

Serial number

On the rating plate, often next to the date of manufacture.

  • 2007716
  • DG106225
  • 2005498
  • DG106220
  • 200

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Malfunction

Alphatec Spine, Inc. — A malfunction was identified in this device. What matters most is whether your particular unit falls inside the affected model, lot or serial range.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.
  2. Check whether the remedy is a software update, and if so confirm afterwards in the device menu that the version actually changed.
  3. If you are a clinic or facility, quarantine affected stock and record the correction in your recall log.
  4. Report device problems to the FDA through MedWatch — that database is where this recall came from.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Alphatec Spine, Inc. — 1950 Camino Vida Roble, Carlsbad, CA, 92008-6505

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Alphatec Spine, Inc. medical devices 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. 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: model number AIX11240. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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