Events

Recall of OPTIBOND SOLO PLUS SELF-ETCH PRIMER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by KERR CORPORATION.

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
    80630
  • Event Risk Class
    III
  • Event Initiated Date
    2006-08-30
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Optibond solo plus self-etch primer and adhesive in chambers of affected lots were mis-packaged/mis-labeled in reverse. application of these products in reverse order may result in compromised bond strength.

Device

OPTIBOND SOLO PLUS SELF-ETCH PRIMER
  • Model / Serial
    Model Catalog: 31966 (Lot serial: 448798); Model Catalog: 31966 (Lot serial: 449556); Model Catalog: 31966 (Lot serial: 451706)
  • Product Description
    OptiBond Solo Plus Self-Etch Adhesive
  • Manufacturer
    KERR CORPORATION

Manufacturer

KERR CORPORATION