FDA Medical devices recall ·
SafeOp Patient Interface recall
- Recall number
- Z-2793-2026
- Date
- (initiated May 13, 2026)
- Company / brand
- Alphatec Spine, Inc.
1950 Camino Vida Roble, Carlsbad, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230
Distribution
US Nationwide distribution in the states of TX, MO, IN.
States: Indiana Missouri Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2793-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.