Events

Rappel de SOFT-CORE RT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par HENRY SCHEIN CANADA INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    53527
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2007-02-28
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    Axis dental has issued a product recall advisory and stop sale notification on its endodontic obturators sold under the soft-core and soft-core rt brand names due to licensing issues.

Device

SOFT-CORE RT
  • Modèle / numéro de série
    Model Catalog: ESC-03020 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ESC-02006 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ESC-02020 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ESC-10020 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ESC-09020 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ESC-08020 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ESC-07020 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ESC-06020 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ESC-05520 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ESC-05020 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ESC-04520 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ESC-04020 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ESC-03520 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 1077365 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 1078152 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 1077062 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 1071474 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 1079380 (Lot
  • Description du dispositif
    SOFT-CORE ENDODONTIC OBTURATORS
  • Manufacturer
    HENRY SCHEIN CANADA INC.

Manufacturer

HENRY SCHEIN CANADA INC.
  • Adresse du fabricant
    NIAGARA-ON-THE-LAKE
  • Société-mère du fabricant (2017)
    Henry Schein Inc
  • Source
    HC