BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software Version: N/A

    Recall: Z-1313-2025 · Reported March 19, 2025

    Enforcement

    Recall Number
    Z-1313-2025
    Event ID
    96246
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    TruAbutment Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    March 19, 2025
    Initiation Date
    December 27, 2023
    Classification Date
    March 11, 2025
    Address
    17666 Fitch, Irvine, CA, 92614-6022, United States

    Description

    Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software Version: N/A

    Reason

    Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately

    Code Info

    Lot Code: KCCBB1216110/ UDI: (01)08800076411791

    Distribution

    US: CA, CO, FL, GA, IA, IL, MD, MN, MS, OH, OR, SD, UT, VA, WA, WI OUS: Japan, Great Britain , Canada

    Quantity

    61 units