BEUDAMED
    FDA Enforcement Class II Terminated

    GENICON EZEE Retrieval, sterile, Rx only.

    Recall: Z-1076-2018 · Reported March 28, 2018

    Enforcement

    Recall Number
    Z-1076-2018
    Event ID
    78655
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Genicon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 28, 2018
    Initiation Date
    July 19, 2017
    Classification Date
    March 16, 2018
    Termination Date
    May 18, 2020
    Address
    6869 Stapoint Ct Ste 112, N/A, Winter Park, FL, 32792-6603, United States

    Description

    GENICON EZEE Retrieval, sterile, Rx only.

    Reason

    Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use.

    Code Info

    Catalog No. 550-000-000; Lot No. I8095/2017-11-08, I8162-2018-01-09, I8162/2020-01-09; UDI: 00877972005223.

    Distribution

    Distributed domestically to FL, IL, MI, TN, UT. Distributed internationally to Dominican Republic, Ireland, Denmark, Spain, Switzerland, United Kingdom.

    Quantity

    2,967 units