Health product recall

Argelite 61+3 (2020-08-01)

Starting date:
August 1, 2020
Posting date:
March 25, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-75193

Last updated: 2021-03-25

Affected Products 

Argelite 61+3

Reason

The Argen Corp. has issued a precautionary and voluntary product removal of a Argelite 61+3 Lot and some Argelite 61+3 Ingots were contaminated with carbon during themanufacturing process. This may lead to bubbling in the opaque or porcelain stages during the fabrication of the final restoration.

Affected products

Argelite 61+3

Lot or serial number

20196781

Model or catalog number

ARGELITE 61+3

Companies
Manufacturer
THE ARGEN CORPORATION
5855 OBERLIN DRIVE
SAN DIEGO
California
UNITED STATES