# FDA recall Z-2793-2026

> **Alphatec Spine, Inc.** · Class II · device recall initiated 2026-05-13.

## Product

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

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-2793-2026
- **Recalling firm:** Alphatec Spine, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-13
- **Report date:** 2026-07-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carlsbad, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2793-2026

## Citation

> AI Analytics. FDA recall Z-2793-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-2793-2026. Source: US FDA. Licensed CC0.

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