Alphatec Spine Recalls SafeOp Patient Interface
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Alphatec Spine, Inc. is recalling three units of the SafeOp Patient Interface due to a software issue that may cause loss of tEMG functionality.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 12, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-device.
What Happened
Alphatec Spine, Inc. initiated a recall of the SafeOp Patient Interface due to a software issue that may cause loss or interruption of triggered electromyography (tEMG) functionality. This can display as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot, potentially resulting in increased operative time and surgical plan change.
Which Products Are Affected
The recall affects the SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System. Three units are affected with UDI-DI 00190376517506 and System Set ID/Patient Interface Serial Numbers: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230. Distribution was limited to US Nationwide in the states of TX, MO, IN. The recall number is Z-2793-2026.
What You Should Do
No specific consumer actions are detailed in the recall notice.
Why This Matters
The Class II recall involves a device that may experience loss of neuromonitoring functionality during surgical use.
Source
FDA recall Z-2793-2026, event ID 98967.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,094 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 12, 2026.
Frequently Asked Questions
Common questions about this FDA recall.