Events

Field Safety Notices about Dycal Radiopaque Calcium Hydroxide Composition Cavity Base/Liner

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by DENTSPLY Caulk.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    SN2011(19)
  • Date
    2011-08-10
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    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 / Alerts
    "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."
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
  • Product Description
    Dycal Radiopaque Calcium Hydroxide Composition Cavity Base/Liner
  • Manufacturer
    DENTSPLY Caulk

Manufacturer

DENTSPLY Caulk