BEUDAMED
    FDA Enforcement Class II Terminated

    REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.

    Recall: Z-1776-2021 · Reported June 9, 2021

    Enforcement

    Recall Number
    Z-1776-2021
    Event ID
    87866
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Meta C.G.M. Spa
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 9, 2021
    Initiation Date
    April 26, 2021
    Classification Date
    June 2, 2021
    Termination Date
    September 12, 2024
    Address
    Via Modena 22-24, Correggio, N/A, Italy

    Description

    REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.

    Reason

    Sterility issues; single use devices labeled as sterile may not have been adequately sterilized

    Code Info

    Lot number: 10-10719, 25-31118, 23-27018, 16-17118, 15-17018, 2-01521, 23-26620, 23-26820, 17-17920, 7-06519, 17-19818, 17-19818, and 13-12818

    Distribution

    Distribution in US states of Texas and Florida

    Quantity

    8,370 units