Events

Recall of Device Recall Myriad System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nico Corp..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74191
  • Event Risk Class
    Class 2
  • Event Number
    Z-2045-2016
  • Event Initiated Date
    2014-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146888
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Motor, surgical instrument, ac-powered - Product Code GEY
  • 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.

Device

Device Recall Myriad System
  • Model / Serial
    13ga, 13cm Myriad Handpiece Part number: NN-8004 Lots 1444664 and 1508994
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : OR, IL, IA, NC, TX, CA, GA, OH, WI, AR, MI, MD, IN.
  • Product Description
    Myriad handpiece || Tissue morcellator
  • Manufacturer
    Nico Corp.

Manufacturer

Nico Corp.
  • Manufacturer Address
    Nico Corp., 250 E 96th St Ste 125, Indianapolis IN 46240-3872
  • Manufacturer Parent Company (2017)
    NICO Corp
  • Source
    USFDA