Class 2 Device Recall SafeOp 3 Neural Informatix System software v2.1

• Date Initiated by Firm: May 13, 2026
• Date Posted: July 23, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2793-2026
• Recall Event ID: 98967
• 510(K)Number: K252842
• Product Classification: Stimulator, electrical, evoked response - Product Code GWF
• Product: SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
• Code Information: UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230
• FEI Number: 2027467
• Recalling Firm/ Manufacturer: Alphatec Spine, Inc.; 1950 Camino Vida Roble; Carlsbad CA 92008-6505
• For Additional Information Contact: 760-431-9286
• Manufacturer 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: 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.
• Quantity in Commerce: 3
• Distribution: US Nationwide distribution in the states of TX, MO, IN.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GWF