BEUDAMED
    FDA Enforcement Class II Terminated

    Myriad handpiece Tissue morcellator

    Recall: Z-2045-2016 · Reported June 29, 2016

    Enforcement

    Recall Number
    Z-2045-2016
    Event ID
    74191
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nico Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 29, 2016
    Initiation Date
    February 24, 2014
    Classification Date
    June 21, 2016
    Termination Date
    June 28, 2016
    Address
    250 E 96th St Ste 125, N/A, Indianapolis, IN, 46240-3872, United States

    Description

    Myriad handpiece Tissue morcellator

    Reason

    This recall has been initiated due to a defective component within the handpiece which will cause the handpiece to fail. The failure will result in the inability to cut tissue with the handpiece, rendering it non-functional. Should this failure occur, a replacement Myriad handpiece will be required. If a replacement handpiece is not available, alternate instrumentation for tissue removal will be necessary.

    Code Info

    13ga, 13cm Myriad Handpiece Part number: NN-8004 Lots 1444664 and 1508994

    Distribution

    US Distribution to the states of : OR, IL, IA, NC, TX, CA, GA, OH, WI, AR, MI, MD, IN.

    Quantity

    63 units