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