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Compoglass F Cavifil (2014-02-12)
- Starting date:
- February 12, 2014
- Posting date:
- April 4, 2014
- 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-38771
Recalled Products
Compoglass F Cavifil
Reason
Based on customer complaints that the material was not fully polymerizing, an analysis of the retained sample confirmed that batch S09397 does not meet the specification in terms of curing depth. (specification greater than and equal to 2.0 mm, test result 1.74 mm). A chemical analysis showed that the amine initiator (Ethyl P-dimethylamino benzoate) was not present in the material (expected 0.4%, result less than 0.002%). The other initiator used in the material, campherquinone, was present in the material. The lack of amine initiator could result in the material curing inadequately.
Affected products
Compoglass F Cavifil
Lot or serial number
S09397
Model or catalog number
546980AN
Companies
- Manufacturer
-
Ivoclar Vivadent AG
Bendererstrasse #2
Schaan
9494
LIECHTENSTEIN