BEUDAMED
    FDA Enforcement Class II Terminated

    Mammary Nodules Localization

    Recall: Z-2491-2021 · Reported September 29, 2021

    Enforcement

    Recall Number
    Z-2491-2021
    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

    Mammary Nodules Localization

    Reason

    Sterility assurance may be compromised.

    Code Info

    Model Number PN2010, Lots: 3620D Model Number PN2012, Lots: 1317 Model Number PN2015, Lots: 3620D Model Number PNA2005, Lots: 5216C Model Number PNA2010, Lots: 3620D Model Number PNA2015, Lots: 3620D Model Number PNAX2005, Lots: 5216C Model Number PNS2010, Lots: 3620D Model Number PNS2015, Lots: 3620D Model Number PNX2010, Lots: 0817A Model Number PR2005, Lots: 5216C, 4920B Model Number PR2007, Lots: 5216C Model Number PR2010, Lots: 3620D Model Number PR2015, Lots: 3620D

    Distribution

    Nationwide

    Quantity

    320 units