Events

Recall of NUCLEUS COCHLEAR IMPLANT SYSTEM

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
    53492
  • Event Risk Class
    Class 2
  • Event Number
    Z-0119-2010
  • Event Date Posted
    2009-11-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85634
  • 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
    Cochlear implant - Product Code MCM
  • Reason
    Cochlear implant device component was mis-labeled.
  • Action
    On September 28, 2009, each surgeon who received a non-magnetic plug after December 5, 2008 was sent a notification letter via courier. The letter described the mislabeling issue and actions for consignees. Customers were requested to return affected product (and the quantity discarded) to the firm and review patient records to verify the implantation of the non-magnetic plug and not the mislabled product (sterile magnetic). Direct questions about the recall by calling at 1-800-523-5798.

Device

NUCLEUS COCHLEAR IMPLANT SYSTEM
  • Model / Serial
    Part No. Z-50100.
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States (AL, AZ, CA, GA, IA, NC, MA, MI, MN, MO, NY, OH, OR, PA, TN, TX and WA), Brazil, and Argentina.
  • Product Description
    Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited.
  • 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