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SafeOp Patient Interface
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MEDICAL DEVICE RECALLMODERATE

SafeOp Patient Interface

Alphatec Spine recalls SafeOp Patient Interface over software issue causing tEMG loss, system faults, and reboot prompts.

What to do

Stop using the affected SafeOp Patient Interface and contact Alphatec Spine for instructions on software update or replacement.

Recalled
Listed
Updated
Recall No.
Z-2793-2026
Agency
FDA
Firm
Alphatec Spine, Inc.
Recall ID
98967
Status
ONGOING

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?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

UDI-DI
00190376517506

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Software Defect recalls

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Editorial summary by Recall Canary · summary updated 2026-07-24 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification