Events

Recall of Cochlear Nucleus CI512 Cochlear Implant

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

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
    59979
  • Event Risk Class
    Class 2
  • Event Number
    Z-0003-2012
  • Event Initiated Date
    2011-09-16
  • Event Date Posted
    2011-10-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104183
  • 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
    Implant, cochlear - Product Code MCM
  • Reason
    Cochlear implant may shut down and cease to function.
  • Action
    Cochlear Americas, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 16, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to examine their inventory and quarantine the affected product. A recall response form was attached to the letter for customers to complete and return. Contact Cochlear Clinic Customer Service at 877-883-3101 for questions concerning this notice.

Device

Cochlear Nucleus CI512 Cochlear Implant
  • Model / Serial
    Part Number Z209051 all codes.
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) and countries in Europe and Australia.
  • Product Description
    Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia. || The cochlear implant is intended to restore a level of auditory sensation via the electrical stimulation of the auditory nerve.
  • Manufacturer
    Cochlear Americas Inc.

Manufacturer

Cochlear Americas Inc.
  • Manufacturer Address
    Cochlear Americas Inc., 13059 E Peakview Ave, Englewood CO 80111-6511
  • Manufacturer Parent Company (2017)
    Cochlear Ltd.
  • Source
    USFDA