BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0324-2026 · Reported November 5, 2025

    Enforcement

    Recall Number
    Z-0324-2026
    Event ID
    97715
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Surgical Theater Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 5, 2025
    Initiation Date
    September 16, 2025
    Classification Date
    October 24, 2025
    Address
    23645 Mercantile Rd Ste M, N/A, Beachwood, OH, 44122-5936, United States

    Description

    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.

    Code Info

    UDI/DI 00860003884126

    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.

    Quantity

    3 units