Events

Recall of IMPRESSION COPING OPEN TRAY CC NP 5X14MM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by NOBEL BIOCARE CANADA 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
    30639
  • Event Risk Class
    III
  • 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
    Nobel biocare has received complaints regarding an incorrect impession coping. after investigation at nobel biocare karlskoga it was discovered that the wrong label and color coding has been used for one batch of the product impression coping open tray cc. the information stated on the label is: impression coping open tray cc np 5 x 14 mm (article no. 36261. lot 742552). the impression coping included in this package is impression coping open tray cc rp 6 x 14 mm (article no. 36266).

Device

IMPRESSION COPING OPEN TRAY CC NP 5X14MM
  • Model / Serial
    Model Catalog: 36261 (Lot serial: 742552)
  • Product Description
    IMPRESSION COPING OPEN TRAY CC NP 5X14MM
  • Manufacturer
    NOBEL BIOCARE CANADA INC

Manufacturer

NOBEL BIOCARE CANADA INC