The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0324-2026·Announced 2025-11-05

Augmented reality spine platform recalled over image layer misalignment in fusion

Surgical Theater is recalling three units of its SpineAR SyncAR SNAP orthopedic augmented reality platform because a software anomaly may misalign secondary image layers.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: misaligned image layers on a surgical augmented reality platform can present inaccurate anatomy, and no injuries are reported.

Plain-English summary

The SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, an orthopedic augmented reality system from Surgical Theater, is being recalled.

A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layers against the primary image layer.

The recall covers 3 units carrying UDI-DI 00860003884126, distributed worldwide including in Michigan, Florida, the District of Columbia, Minnesota, California, Texas, New Jersey, Pennsylvania, Arizona, New York, Kentucky, Indiana and West Virginia. The FDA has classified the action as Class II.

The enforcement record describes the software anomaly and reports no injuries. Sites running the affected version should follow the firm's instructions.

The recalled product

Product
SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality
Manufacturer
Surgical Theater Inc
Category
Medical Device — Imaging software
Hazard
Affected units
3

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI/DI 00860003884126

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Part of a larger recall action

This product is one of 7 recalled by Surgical Theater Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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