Events

Rappel de HERCULITE ULTRA ENAMEL - UNIDOSE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par PATTERSON DENTAL 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
    16063
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2015-02-06
  • 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
    Kerr corporation received complaints that the herculite ultra product may be difficult to extrude or may not perform as intended. the composite does not extrude easily. any composite extruded was determined to exhibit signs of dryness and was not workable upon manipulation.

Device

HERCULITE ULTRA ENAMEL - UNIDOSE
  • Modèle / numéro de série
    Model Catalog: 34348 (Lot serial: 4667889); Model Catalog: 34448 (Lot serial: 4662092); Model Catalog: 34348 (Lot serial: 4662092); Model Catalog: 34448 (Lot serial: 4678965); Model Catalog: 34348 (Lot serial: 4678965); Model Catalog: 34448 (Lot serial: 4662093); Model Catalog: 34348 (Lot serial: 4662093); Model Catalog: 34448 (Lot serial: 4734549); Model Catalog: 34348 (Lot serial: 4734549); Model Catalog: 34448 (Lot serial: 4779744); Model Catalog: 34348 (Lot serial: 4779744); Model Catalog: 34448 (Lot serial: 4791138); Model Catalog: 34348 (Lot serial: 4791138); Model Catalog: 34448 (Lot serial: 4791140); Model Catalog: 34348 (Lot serial: 4791140); Model Catalog: 34448 (Lot serial: 4786373); Model Catalog: 34348 (Lot serial: 4786373); Model Catalog: 34448 (Lot serial: 4857439); Model Catalog: 34348 (Lot serial: 4857439); Model Catalog: 34448 (Lot serial: 4861157); Model Catalog: 34348 (Lot serial: 4861157); Model Catalog: 34448 (Lot serial: 4863611); Model Catalog: 34348 (Lot serial: 4863611); Model Catal
  • Description du dispositif
    HERCULITE ULTRA ENAMEL - UNIDOSE
  • Manufacturer
    PATTERSON DENTAL CANADA INC.

Manufacturer

PATTERSON DENTAL CANADA INC.