BEUDAMED
    FDA Enforcement Class II Terminated

    Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715

    Recall: Z-0144-2022 · Reported October 27, 2021

    Enforcement

    Recall Number
    Z-0144-2022
    Event ID
    88543
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ADRIA SRL
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 27, 2021
    Initiation Date
    May 17, 2021
    Classification Date
    October 19, 2021
    Termination Date
    November 6, 2023
    Address
    Via Modena 46, Societa Unipersonale, San Giovanni In Persiceto, N/A, N/A, Italy

    Description

    Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715

    Reason

    The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.

    Code Info

    Lot Number: AD0316/20

    Distribution

    The products were distributed to the following US states: NJ and NY.

    Quantity

    N/A