Alphatec recalls SafeOp Patient Interface (REF AIX11240) due to software issues that may cause system faults during surgery, potentially increasing operative time. Affected units have specific serial numbers.
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.
Alphatec is recalling SafeOp Patient Interface devices (REF AIX11240) because a software issue can cause system faults during surgery, leading to longer procedures and changes in surgical plans. This affects surgeons and surgical teams using the device.
The device may experience loss or interruption of triggered electromyography (tEMG) functionality during surgery. This causes system faults, communication loss between the Patient Interface and tablet, and prompts for system reboots. These issues can increase surgical time and require changes to the surgical plan.
Surgeons and surgical teams using the SafeOp Patient Interface device during procedures are most at risk. The recall affects specific units with known serial numbers.
Check for the model reference AIX11240 on the device. Affected units have specific serial numbers: 2007716/DG106225, 2005498/DG106220, or 2005490/DG106230.
Look for the serial numbers listed: 2007716/DG106225, 2005498/DG106220, or 2005490/DG106230.
The device may experience loss or interruption of triggered electromyography (tEMG) functionality during surgery, causing system faults and communication loss between the Patient Interface and tablet.
This issue may result in increased operative time and changes to the surgical plan.
No, the recall does not require immediate stop use; affected units have specific serial numbers to check.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-2793-2026 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-2793-2026 from Alphatec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
