Events

Recall of NOBELACTIVE IMPLANT

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
    120368
  • Event Risk Class
    II
  • Event Initiated Date
    2012-02-06
  • 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
    On january 27 2012 nobel biocare usa became aware that the nobelactive internal rp 5.0x15mm lot number 753360 was 13 mm in length instead of 15 mm. this batch has been verified to have the incorrect length compared to the length stated on the label.

Device

NOBELACTIVE IMPLANT
  • Model / Serial
    Model Catalog: 34140 (Lot serial: 753360)
  • Product Description
    NOBELACTIVE RP 5X15MM
  • Manufacturer
    NOBEL BIOCARE CANADA INC

Manufacturer

NOBEL BIOCARE CANADA INC