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HELIOSEAL CLEAR (2016-02-05)
- Starting date:
- February 5, 2016
- Posting date:
- February 26, 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-57290
Affected products
A. HELIOSEAL CLEAR
Reason
A wrong photo-initiator was used in the production batch U30755 of Helioseal Clear. This failure can lead to incomplete curing of the sealant if mono-wave LED curing lights are used.
Affected products
A. HELIOSEAL CLEAR
Lot or serial number
U29336
U33966
U50469
Model or catalog number
558520AN
558521AN
Companies
- Manufacturer
-
Ivoclar Vivadent AG
Bendererstrasse #2
Schaan
9494
LIECHTENSTEIN