Dental Composite (2016-03-02)

Starting date:

March 2, 2016

Posting date:

April 7, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-57850

• Reason
• Affected products

Affected products 

A. XRV Herculite UNIDOSE

B. Point 4

C. Herculite Ultra XL - UNIDOSE

D. Herculite Ultra Enamel - UNIDOSE

E.Herculite Ultra Dentin - UNIDOSE

F. Herculite Ultra Light Incisal - UNIDOSE

G. Premise UNIDOSE

H. Premise UNIDOSE OPAQUE

I. Premise UNIDOSE TRANSLUCENT

Reason

The production process used to package the affected lots may lead to the presence of plastic particulates in the dental composite material.  The particulate is unlikely to cause any adverse health consequences.

Affected products