BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style 1 size 6 left UDI-DI code: B4905001065 500-106-6 Pectoral Implant style 1 size 6 right UDI-DI code: B4905001066 500-200-5 Pectoral Implant style 2 size 0 left UDI-DI code: B4950020205 500-200-6 500-201-5 500-201-6 500-202-5 500-202-6 500-403-5 500-403-6

    Recall: Z-0948-2026 · Reported December 24, 2025

    Enforcement

    Recall Number
    Z-0948-2026
    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 Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style 1 size 6 left UDI-DI code: B4905001065 500-106-6 Pectoral Implant style 1 size 6 right UDI-DI code: B4905001066 500-200-5 Pectoral Implant style 2 size 0 left UDI-DI code: B4950020205 500-200-6 500-201-5 500-201-6 500-202-5 500-202-6 500-403-5 500-403-6

    Reason

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

    Code Info

    Pectoral Implant Model/Catalog Number: 500-106-5 UDI-DI code: B4905001065 Lot Number: 24-03-002 Model/Catalog Number: 500-106-6 UDI-DI code: B4905001066 Lot Number: 24-03-003 Model/Catalog Number: 500-200-5 UDI-DI code: B4905002005 Lot Numbers: 24-12-004 25-02-002 Model/Catalog Number: 500-200-6 UDI-DI code: B4905002006 Lot Numbers: 24-12-005 25-02-003 Model/Catalog Number: 500-201-5 UDI-DI code: B4905002015 Lot Numbers: 24-11-015 25-02-004 25-05-002 Model/Catalog Number: 500-201-6 UDI-DI code: B4905002016 Lot Numbers: 24-12-017 25-02-005 Model/Catalog Number: 500-202-5 UDI-DI code: B4905002025 Lot Numbers: 24-12-018 25-03-018 Model/Catalog Number: 500-202-6 UDI-DI code: B4905002026 Lot Numbers: 24-09-015 25-03-019 Model/Catalog Number: 500-403-5 UDI-DI code: B4905004035 Lot Number: 25-04-020 Model/Catalog Number: 500-403-6 UDI-DI code: B4905004036 Lot Number: 25-04-021

    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

    41 implants