Events

Recall of 30 DEG MULTI-U AB NOBELACTIVE INTERNAL RP

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
    46767
  • Event Risk Class
    III
  • Event Initiated Date
    2012-03-19
  • 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 a customer complaint that select abutments of 30 degree multi-u ab nobelactive int rp 3.5mm (product number 34369/lot number 464886) have been machined incorrectly. the portion of the abutment that fits into the implant was machined larger than specifications. the abutment will therefore not fit into the implant.

Device

30 DEG MULTI-U AB NOBELACTIVE INTERNAL RP
  • Model / Serial
    Model Catalog: 34369 (Lot serial: 464886)
  • Product Description
    30 DEGREE MULTI-UNIT ABUTMENT NOBELACTIVE INT RP 3.5MM
  • Manufacturer
    NOBEL BIOCARE CANADA INC

Manufacturer

NOBEL BIOCARE CANADA INC