Events

Recall of NOBELREPLACE CONICAL CONNECTION NP

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
    26736
  • Event Risk Class
    II
  • Event Initiated Date
    2015-03-10
  • 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 become aware through receiving inspection that the santoprene caps (molded packaging components) were not according to nobel biocare specification a suspicious "stickiness" effect was observed.

Device

NOBELREPLACE CONICAL CONNECTION NP
  • Model / Serial
    Model Catalog: 36701 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    NOBELREPLACE CONICAL CONNECTION NP
  • Manufacturer
    NOBEL BIOCARE CANADA INC

Manufacturer

NOBEL BIOCARE CANADA INC