Z-0324-2026 Class II
FDA device recall Z-0324-2026 was initiated by Surgical Theater Inc on September 16, 2025 and is designated Class II. 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… Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 5, 2025
- Initiation Date
- September 16, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
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.
Distribution Pattern
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.
Code Information
UDI/DI 00860003884126