Events

Recall of PEAK SE PRIMER REFILL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ULTRADENT PRODUCTS 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
    131506
  • Event Risk Class
    III
  • Event Initiated Date
    2012-07-03
  • 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
    The syringe in the peak se primer kit was incorrectly labelled as peak lc bond resin. if peak se primer was mistakenly used as the bonding resin due to mislabelling a failure to the dental restoration could occur due to inaqdequate adhesion.

Device

PEAK SE PRIMER REFILL
  • Model / Serial
    Model Catalog: 5135 (Lot serial: B6Z4K)
  • Product Description
    PEAK SE PRIMER REFILL
  • Manufacturer
    ULTRADENT PRODUCTS INC.

Manufacturer

ULTRADENT PRODUCTS INC.