Events

Rappel de DYCAL RADIOPAQUE CALCIUM HYDROXIDE COMPOSITION

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par DENTSPLY LLC ALSO DBA DENTSPLY CAULK.

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
    50731
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2010-02-16
  • 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
    Several recent lots of dycal may exhibit faster setting characteristics than is normal for these products. the catalyst may also seem thicker than usual when extruded from the tube.

Device

DYCAL RADIOPAQUE CALCIUM HYDROXIDE COMPOSITION
  • Modèle / numéro de série
    Model Catalog: 623451Y (Lot serial: 091013); Model Catalog: 623450 (Lot serial: 091013); Model Catalog: 623401Y (Lot serial: 091013); Model Catalog: 623400 (Lot serial: 091013); Model Catalog: 623702 (Lot serial: 091106); Model Catalog: 623701 (Lot serial: 091106); Model Catalog: 623451Y (Lot serial: 091106); Model Catalog: 623450 (Lot serial: 091106); Model Catalog: 623401Y (Lot serial: 091106); Model Catalog: 623400 (Lot serial: 091106); Model Catalog: 623702 (Lot serial: 091002); Model Catalog: 623701 (Lot serial: 091002); Model Catalog: 623451Y (Lot serial: 091002); Model Catalog: 623450 (Lot serial: 091002); Model Catalog: 623401Y (Lot serial: 091002); Model Catalog: 623400 (Lot serial: 091002); Model Catalog: 623702 (Lot serial: 090925); Model Catalog: 623701 (Lot serial: 090925); Model Catalog: 623451Y (Lot serial: 090925); Model Catalog: 623450 (Lot serial: 090925); Model Catalog: 623401Y (Lot serial: 090925); Model Catalog: 623400 (Lot serial: 090925); Model Catalog: 623702 (Lot serial: 091022); Mod
  • Description du dispositif
    Dycal Radiopaque Calcium Hydroxide Composition Cavity Base/Liner
  • Manufacturer
    DENTSPLY LLC ALSO DBA DENTSPLY CAULK

Manufacturer

DENTSPLY LLC ALSO DBA DENTSPLY CAULK