SafeOp Patient Interface…

Date

July 29, 2026

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

Alphatec Spine, Inc.

Product

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

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.

Distribution pattern

US Nationwide distribution in the states of TX, MO, IN.

Quantity

3

Codes and lots

UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230

Recall started

May 13, 2026

Device type

Stimulator, Electrical, Evoked Response

Root cause (FDA)

Software Design Change

What the company told customers

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.

Recall number

Z-2793-2026

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2793-2026. The agency record governs; check it and the company before acting.