BEUDAMED
    FDA Recall Terminated

    Myriad handpiece Tissue morcellator

    Recall: Z-2045-2016 · Initiated February 24, 2014

    Recall

    Recall Number
    Z-2045-2016
    Event Number
    74191
    Firm
    Nico Corp.
    FEI Number
    3007456622
    Product Code
    GEY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 24, 2014
    Terminated
    June 28, 2016
    Address
    250 E 96th St, Ste 125, Indianapolis, IN, 46240-3872

    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.

    Action

    NICO sent an Urgent: NICO Myriad Handpiece Recall Notification on February 24, 2014, to all affected customers requesting return of the affected product. The recall notification included a description of the reason for the recall, affected product, customer responsibilities, and instructions for responding to the formal recall notification. If you have any questions regarding this matter, please call (317) 660-7118, ext. 104.

    Distribution

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

    Quantity

    63 units