BEUDAMED
    FDA Enforcement Class II Ongoing

    STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dental

    Recall: Z-0489-2023 · Reported December 21, 2022

    Enforcement

    Recall Number
    Z-0489-2023
    Event ID
    91124
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stradis Medical, LLC dba Stradis Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 21, 2022
    Initiation Date
    November 2, 2022
    Classification Date
    December 14, 2022
    Address
    3025 Northwoods Pkwy, N/A, Peachtree Corners, GA, 30071-1524, United States

    Description

    STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dental

    Reason

    Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

    Code Info

    UDI/DI (case) M75240649ECS1, UDI/DI (kit)M75240649ECS0, Serial/Lot Numbers: 22270491425

    Distribution

    US nationwide distribution, and Canada.

    Quantity

    6 units