Events

Recall of PATIENT SPECIFIC INSTRUMENT AND PLANNING KIT - ORTHOGNATHIC KIT TWO SPLINTS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MATERIALISE N.V..

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
    140367
  • Event Risk Class
    III
  • Event Initiated Date
    2013-11-19
  • 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
    A box contained the incorrect case report. case mc13-ova-ogo contained the case report for case mu13-jus-jaz.

Device

PATIENT SPECIFIC INSTRUMENT AND PLANNING KIT - ORTHOGNATHIC KIT TWO SPLINTS
  • Model / Serial
    Model Catalog: SD900.008 (Lot serial: MC13-OVA-OGO)
  • Product Description
    PATIENT SPECIFIC INSTRUMENT AND PLANNING KIT - ORTHOGNATHIC KIT TWO SPLINTS
  • Manufacturer
    MATERIALISE N.V.

Manufacturer

MATERIALISE N.V.
  • Manufacturer Address
    LEUVEN
  • Manufacturer Parent Company (2017)
    Materialise Nv
  • Source
    HC