BEUDAMED
    FDA Enforcement Class II Terminated

    General Manual surgical instrument

    Recall: Z-2493-2021 · Reported September 29, 2021

    Enforcement

    Recall Number
    Z-2493-2021
    Event ID
    88430
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    M.D.L. S.r.l.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 29, 2021
    Initiation Date
    August 5, 2021
    Classification Date
    September 20, 2021
    Termination Date
    May 4, 2026
    Address
    Via Tavani N. 1/A, Delebio, N/A, Italy

    Description

    General Manual surgical instrument

    Reason

    Sterility assurance may be compromised.

    Code Info

    Model MGC1413, Lot Numbers: 0817A Model MGC1825, Lot Numbers: 0817A Model MGP1410, Lot Numbers: 5216C Model MGP1412, Lot Numbers: 5216C Model MGP1612, Lot Numbers: 5216C Model MGP1820, Lot Numbers: 5216C Model MGP1825, Lot Numbers: 0817A Model PC1610, Lot Numbers: 3620D Model PC1810, Lot Numbers: 3620D Model PC1815, Lot Numbers: 1217B Model PM14075, Lot Numbers: 5216C Model PM1410, Lot Numbers: 3620D Model PM14114, Lot Numbers: 5216C Model PM1415, Lot Numbers: 5216C Model PM16075, Lot Numbers: 5216C Model PM1610, Lot Numbers: 3620D Model PM16114, Lot Numbers: 5216C Model PM1615, Lot Numbers: 5216C Model PM18075, Lot Numbers: 5216C Model PM18114, Lot Numbers: 5216C Model PM1815, Lot Numbers: 5216C Model VE1410, Lot Numbers: 3620D Model VES1825, Lot Numbers: 1417A

    Distribution

    Nationwide

    Quantity

    4120 units