BEUDAMED
    FDA Recall Terminated

    GENICON EZEE Retrieval, sterile, Rx only.

    Recall: Z-1076-2018 · Initiated July 19, 2017

    Recall

    Recall Number
    Z-1076-2018
    Event Number
    78655
    Firm
    Genicon, Inc.
    FEI Number
    3002590791
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 19, 2017
    Terminated
    May 18, 2020
    Address
    6869 Stapoint Ct, Ste 112, Winter Park, FL, 32792-6603

    Description

    GENICON EZEE Retrieval, sterile, Rx only.

    Reason

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

    Action

    Consignees were notified via email on 07/19/2017. Instructions included

    Distribution

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

    Quantity

    2,967 units