CLASS II ONGOING Device recall · Reported 29 Jul 2026 · FDA Enforcement Report
SafeOp Patient Interface recalled by Alphatec Spine
Alphatec Spine is recalling SafeOp Patient Interface, distributed nationwide in the US. The recall was initiated on 13 May 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2793-2026
- FDA event ID
- 98967
- Recalling firm
- Alphatec Spine, Carlsbad, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 May 2026
- FDA classified
- 23 Jul 2026
- Reported
- 29 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 13 May 2026 | Recall initiated by company | |
| 23 Jul 2026 | Classified by FDA | +71 days |
| 29 Jul 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Where it was distributed
US Nationwide distribution in the states of TX, MO, IN.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230
Where was it sold?
US Nationwide distribution in the states of TX, MO, IN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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