BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B4904012025 401-202-6 Malar Implant style 2 size 2 right UDI-DI code: B4904012026

    Recall: Z-0947-2026 · Reported December 24, 2025

    Enforcement

    Recall Number
    Z-0947-2026
    Event ID
    97704
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DSAART LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 24, 2025
    Initiation Date
    September 26, 2025
    Classification Date
    December 18, 2025
    Address
    2950 Arrowhead Dr, Carson City, NV, 89706-0488, United States

    Description

    Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B4904012025 401-202-6 Malar Implant style 2 size 2 right UDI-DI code: B4904012026

    Reason

    Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

    Code Info

    Malar Implant Model/Catalog Number: 401-202-5 UDI-DI code: B4904012025 Lot Number: 24-01-014 Model/Catalog Number: 401-202-6 UDI-DI code: B4904012026 Lot Number: 24-01-015

    Distribution

    U.S.: AR, AZ, CA, CO, CT, DC, FL, GA, KY, IL, MA, MD, MI, MN, MS, NE, NJ, NY, OH, OK, PA, PR, TX, UT, VA, WA, and WI O.U.S.: N/A

    Quantity

    2 implants