BEUDAMED
    FDA Enforcement Class II Terminated

    INSORB SUBCUTICULAR SKIN STAPLER, REF 2030

    Recall: Z-0078-2019 · Reported October 17, 2018

    Enforcement

    Recall Number
    Z-0078-2019
    Event ID
    81008
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Incisive Surgical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 17, 2018
    Initiation Date
    August 29, 2018
    Classification Date
    October 5, 2018
    Termination Date
    March 18, 2019
    Address
    14405 21st Ave N Ste 130, Plymouth, MN, 55447-4638, United States

    Description

    INSORB SUBCUTICULAR SKIN STAPLER, REF 2030

    Reason

    Possible compromise of the sterile barrier integrity

    Code Info

    UDI 10867516000101 Lot Number 182801

    Distribution

    Israel

    Quantity

    1200 units