Events

Recall of Device Recall Premise

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kerr 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
    34769
  • Event Risk Class
    Class 2
  • Event Number
    Z-0691-06
  • Event Initiated Date
    2006-03-03
  • Event Date Posted
    2006-03-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44623
  • 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
    Agent, Tooth Bonding, Resin - Product Code KLE
  • Reason
    The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
  • Action
    A total of one hundred thirty five (135) consignees were sent the recall communication via USPS 1st class mail and international fax/mail on March 3 and 6, 2006, respectively. There will be an additional thirty seven (37) letters to be sent to consignees in Australia and three (3) letters to be sent to consignees in New Zealand once the Australian Therapeutic Goods Administration approves of a differently formatted letter. The consignees were instructed to complete the Return Form and return any affected product in their inventory. They were also requested to recover any affected product that they may have shipped to their customers.

Device

Device Recall Premise
  • Model / Serial
    Lot Numbers: 428730
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Belgium, Canada, Denmark, Germany, Hungary, Italy, Russia, Spain, United Kingdom, & New Zealand.
  • Product Description
    Tooth bonding resin. Premise Master Syringe Kit, Part Number 32611, Lot Numbers 428730
  • Manufacturer
    Kerr Corp

Manufacturer

Kerr Corp
  • Manufacturer Address
    Kerr Corp, 1717 W Collins Ave, Orange CA 92867-5422
  • Source
    USFDA