Recall Z-0324-2026— Surgical Theater Inc

Name: FDA recall Z-0324-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-16

Class II · Ongoing

Class II FDA medical device recall by Surgical Theater Inc, initiated 2025-09-16. It names one FDA 510(k) clearance: K243623. Product: SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality. Reason: 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 layer(s) to the primary image layer..

Recalling firm: Surgical Theater Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-09-16
Firm location: Beachwood, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K243623 — SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.·cleared 2024-12-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality

Reason for recall

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 layer(s) to the primary image layer.

Data sourced from openFDA. This site is unofficial and independent of the FDA.