Events

Recall of REPLACE ESTHETIC ABUTMENT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by NOBEL BIOCARE USA LLC.

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
    39422
  • Event Risk Class
    II
  • Event Initiated Date
    2002-06-14
  • 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
    Poor rework instructions caused mix of sterile and nonsterile components. fda recall # z-0295-2.

Device

REPLACE ESTHETIC ABUTMENT
  • Model / Serial
    Model Catalog: (Lot serial: 322668 321440 322084); Model Catalog: (Lot serial: 320151 320403 320926 320406); Model Catalog: (Lot serial: 320163 321748 320929 320930); Model Catalog: (Lot serial: 321441); Model Catalog: (Lot serial: 322081); Model Catalog: (Lot serial: 320180); Model Catalog: (Lot serial: 322664); Model Catalog: (Lot serial: 320174); Model Catalog: (Lot serial: 320927)
  • Product Description
    EASY ABUTMENT SET AND IMPRESSION CAP
  • Manufacturer
    NOBEL BIOCARE USA LLC

Manufacturer

NOBEL BIOCARE USA LLC
  • Manufacturer Address
    YORBA LINDA
  • Source
    HC