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

Check your package for

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

Why: 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.
Distributed: US Nationwide distribution in the states of TX, MO, IN.
Company: Alphatec Spine, Inc.
Announced: 29 July 2026
Recall began: 13 May 2026

Read the official notice

Every recall — food, medication, or medical device — is shown word-for-word from the official FDA or USDA notice, with a link straight to it. Nothing here is summarised, reworded, or filled in. This site is not affiliated with any government agency.