Events

Avis De Sécurité sur Dycal Radiopaque Calcium Hydroxide Composition Cavity Base/Liner

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par DENTSPLY Caulk.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Numéro de l'événement
    SN2011(19)
  • Date
    2011-08-10
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/dycal-radiopaque-calcium-hydroxide-composition-cavity-base-liner&id=d896f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Notes supplémentaires dans les données
  • Cause
    Dentsply has become aware that certain lots of dycal may exhibit faster setting times than is normal for these products.
  • Action
    DENTSPLY has been unsuccessful in their attempts to locate all devices affected by this field safety corrective action (FSCA), as one of the distributors in Ireland, O’Neill Dental Ltd., has ceased trading and there are no customer records available to assist traceability.  The IMB advises that users:  • Identify the affected devices in your facility.  • If you have affected devices, follow the manufacturer’s recommendations as outlined in the attached FSN and contact DENTSPLY to arrange for return

Device

Dycal Radiopaque Calcium Hydroxide Composition Cavity Base/Liner
  • Modèle / numéro de série
  • Description du dispositif
    Dycal Radiopaque Calcium Hydroxide Composition Cavity Base/Liner
  • Manufacturer
    DENTSPLY Caulk

Manufacturer

DENTSPLY Caulk