Events

Recall of Device Recall Cochlear Nucleus Sterile Silicone Template

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
    71509
  • Event Risk Class
    Class 2
  • Event Number
    Z-2155-2015
  • Event Initiated Date
    2015-06-05
  • Event Date Posted
    2015-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138017
  • 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 americas is recalling nucleus sterile silicone template ci24re/ci422 part number z421736 because expired product was distributed.
  • Action
    Cochlear sent an Urgent Medical Device Recall letter dated June 5, 2015 via Fed-Ex shipment. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return affected products for replacement.

Device

Device Recall Cochlear Nucleus Sterile Silicone Template
  • Model / Serial
    Lot numbers: COH471122 Expiration 5/6/15 and Lot COH471123 Expiration 4/24/15
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution to CO, OH, OR, MI, and CA.
  • Product Description
    Cochlear Nucleus Sterile Silicone Template || Product Usage: || The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes
  • Manufacturer
    Cochlear Americas Inc.

Manufacturer

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