Class II — Surgical Theater Inc
| Recalling firm | Surgical Theater, Inc. |
|---|---|
| Registered facility | SURGICAL THEATER, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality |
| Quantity | 3 units |
| 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. |
| Initiated | 2025-09-16 |
| Classified | 2025-10-24 |
| Terminated | 2026-08-03 |
| Recall number | Z-0324-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Surgical Theater Inc (Z-0324-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97715/
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