SafeOp Patient Interface
Alphatec Spine recalls SafeOp Patient Interface over software issue causing tEMG loss, system faults, and reboot prompts.
Stop using the affected SafeOp Patient Interface and contact Alphatec Spine for instructions on software update or replacement.
Why it was recalled
Alphatec Spine is recalling the SafeOp Patient Interface, REF AIX11240, part of the SafeOp 3 Neural Informatix System, due to a software issue that may cause loss or interruption of triggered electromyography (tEMG) functionality during use. This can result in system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot, potentially leading to increased operative time and surgical plan changes.
Is mine affected?
This recall covers the product below. If you have it, yours is affected.
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Official source
Other recent recalls from Alphatec Spine, Inc.
Editorial summary by Recall Canary · last updated 2026-07-24 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification