Alphatec Spine, Inc.: Stimulator, Electrical, Evoked Response
- Recalling firm
- Alphatec Spine, Inc.
- Product
- SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-13
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of TX, MO, IN.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/7e1f9506-3fd6-4dac-92f2-abc365d05b5e