Events

Recall of NC OCCLUSAL SCREW

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by STRAUMANN CANADA LIMITED.

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
    41522
  • Event Risk Class
    II
  • Event Initiated Date
    2012-07-23
  • 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
    A customer complaint reports that the article 022.2630 - nc screw for cares abutment zr02 and ifu contains an incorrect screw. the investigation has confirmed that there has been a mix-up and a limited number of articles 022.2630 - nc screw for cares abutment zr02 and ifu incorrectly contain an rc screw and 022.4630 - rc screw for cares abutment zr02 and ifu incorrectly contain an nc screw.

Device

NC OCCLUSAL SCREW
  • Model / Serial
    Model Catalog: 025.2906 (Lot serial: EM179); Model Catalog: 022.2630 (Lot serial: EM177); Model Catalog: 025.2906 (Lot serial: EM177); Model Catalog: 022.2630 (Lot serial: EM175); Model Catalog: 025.4906 (Lot serial: EM397); Model Catalog: 022.4630 (Lot serial: EM398); Model Catalog: 025.4906 (Lot serial: EM398); Model Catalog: 022.4630 (Lot serial: EM397); Model Catalog: 022.2630 (Lot serial: EM179); Model Catalog: 025.2906 (Lot serial: EM175)
  • Product Description
    ARTICLE 022.2630 NC SCREW FOR CARES ABUTMENT ZR02 AND IFU
  • Manufacturer
    STRAUMANN CANADA LIMITED

Manufacturer

STRAUMANN CANADA LIMITED