FDA recall Z-0324-2026

Surgical Theater Inc · Class II · device

Product

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.

Distribution

Worldwide - US Nationwide distribution in the states of MI, FL, DC, MN, CA, TX, NJ, PA, AZ, NY, KY, IN, WV and the countries of Italy, Germany, Israel, UK.

Key facts

Status: Ongoing
Initiation date: 2025-09-16
Report date: 2025-11-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Beachwood, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0324-2026