Events

Recall of Device Recall Kerr Corporation OptiBond Solo Plus SelfEtch Adhesive System

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
    36200
  • Event Risk Class
    Class 2
  • Event Number
    Z-1521-06
  • Event Initiated Date
    2006-08-29
  • Event Date Posted
    2006-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48183
  • 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
    Tooth bonding adhesive - Product Code KLE
  • Reason
    Mis-pack/mis-label: the optibond self etch primer and optibond solo plus adhesive in the chambers were mis-packaged/mis-labeled in reverse order. application of these products in reverse order may result in compromised bond strength.
  • Action
    A total of thirty-four (34) consignees were sent the recall communication via USPS 1st class mail on August 29, 2006. There will be an additional five (5) letters that will be sent to consignees in Europe once the recall communication is translated into their respective languages. 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. Periodic effectiveness checks will be conducted in order to follow up with non-responders.

Device

Device Recall Kerr Corporation OptiBond Solo Plus SelfEtch Adhesive System
  • Model / Serial
    Lot numbers: 448798, 449556 and 451706
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    World wide; USA and countries of Australia, Belgium, Canada, China, France, Sweden and United Kingdom
  • Product Description
    OptiBond Solo Plus Self-Etch Adhesive System, Part Number 31966
  • Manufacturer
    Kerr Corp

Manufacturer

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