{"recall":{"id":"fda-device-98967","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Alphatec Spine, Inc. recalls SafeOp Patient Interface","firm":"Alphatec Spine, Inc.","date":"2026-05-13","reported":"2026-07-29","status":"Ongoing","classification":"Class II","products":[{"name":"SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System","code":"UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230","quantity":"3","number":"Z-2793-2026","classification":"Class II"}],"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.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of TX, MO, IN.","nationwide":true,"states":[],"units":"3","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98967","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"82d7fef6ab80c119","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98967","record":[{"status":"Ongoing","city":"Carlsbad","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"98967","recalling_firm":"Alphatec Spine, Inc.","address_1":"1950 Camino Vida Roble","address_2":"N/A","postal_code":"92008-6505","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"N/A","distribution_pattern":"US Nationwide distribution in the states of TX, MO, IN.","recall_number":"Z-2793-2026","product_description":"SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System","product_quantity":"3","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.","recall_initiation_date":"20260513","center_classification_date":"20260723","report_date":"20260729","code_info":"UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230"}]}}