Events

Recall of Device Recall Nico Myriad

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
    72015
  • Event Risk Class
    Class 2
  • Event Number
    Z-2767-2015
  • Event Initiated Date
    2015-07-29
  • Event Date Posted
    2015-09-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139582
  • 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
    Two cables within the console were inadvertently twisted during manufacturing. the individual wires within the cables may break and/or contact one another where the cables terminate into two connectors. when these wires break or contact one another (i.E., short), various types of malfunction may occur with the console. one type of malfunction may result in unexpected aspiration increase.
  • Action
    The firm, Nico Corporation, sent an "URGENT: NICO Console Recall" notification dated 7/31/15 via fax to its customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The customers were instructed to return the console and complete and return the Recall Response Form via fax to: 317-683-0305 or email to: Jay.Dittman@niconeuro.com. The firm will provide customers with a Myriad Console loaner kit. If you have any questions, contact Director of Quality and Regulatory, at 317-660-7118 ext 104 or email to: jay.dittman@nicneuro.com.

Device

Device Recall Nico Myriad
  • Model / Serial
    Model number NN-7000  SN: 00231, 00232, 00242, 00245, 00248, 00250
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to states of: MD, IN, CA, and NC.
  • Product Description
    NICO Myriad Console || Model number NN-7000 || The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of a reusable console with foot pedal and a disposable handpiece. || For the morcellation and removal of tissue during pelviscopic, laparoscopic, percutaneous and open surgical procedures whenever access to the surgical site is limited.
  • Manufacturer
    Nico Corp.

Manufacturer

Nico Corp.
  • Manufacturer Address
    Nico Corp., 250 E 96th St, ste 125, Indianapolis IN 46240-3781
  • Manufacturer Parent Company (2017)
    NICO Corp
  • Source
    USFDA