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Dycal Radiopaque Calcium Hydroxide Composition Cavity Base/Liner

Notice type: Recall

Date: 10/08/2011

Product name or type:
Dycal Radiopaque Calcium Hydroxide Composition Cavity Base/Liner

Reference:
SN2011(19)

Manufacturer Or Supplier:
DENTSPLY Caulk, USA.

Target Audience:
Dental Practitioners
Distributors

Problem Or Issue:
DENTSPLY has become aware that certain lots of Dycal may exhibit faster setting times than is normal for these products

Background Information Or Related Documents:
DENTSPLY has confirmed that this issue is limited to specific lot numbers (see attached field safety notice, FSN). DENTSPLY has published a FSN and has undertaken a recall of the affected product lots.

Dycal Radiopaque Calcium Hydroxide Composition Cavity Base/Liner Document

Actions To Be Taken:
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

Further Information:
Enquiries to the European authorised representative should be addressed to:

Mr. Torsten Riedel
Divisional Complaint Officer / Quality Assurance
DENTSPLY DeTrey GmbH
De-Trey-Straße 1
78467 Konstanz
Germany

Telephone: +49 75 31 / 5 83 2 61
Fax: +49 75 31 / 5 83 660 710
E-mail: torsten.riedel@dentsply.com

All adverse incidents relating to a medical device should be reported to the:

Health Products Regulatory Authority
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2

Telephone: +353-1-6764971
Fax: +353-1-6344033
Website: www.hpra.ie

Please click here to download PDF version of Safety Notice

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