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IVOCLAR VIVADENT AG products (2016-07-01)
- Starting date:
- July 1, 2016
- Posting date:
- July 19, 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-59396
Affected products
- TELIO CS C & B STARTER PACK
- OPTRAPOL NG ASSORTMENT
- OPTRAPOL NG REFILLS
Reason
Based on 2 customer complaints that the material was wearing faster than expected, the manufacturing process is suspected to be the cause of the issue. After a few seconds of polishing with moderate force, parts of the cups are breaking away.
Affected products
A. TELIO CS C & B STARTER PACK
Lot or serial number
V19582
Model or catalog number
628244AN
Companies
- Manufacturer
-
Ivoclar Vivadent AG
Bendererstrasse #2
Schaan
9494
LIECHTENSTEIN
B. OPTRAPOL NG ASSORTMENT
Lot or serial number
VL0705
Model or catalog number
634464
Companies
- Manufacturer
-
Ivoclar Vivadent AG
Bendererstrasse #2
Schaan
9494
LIECHTENSTEIN
C. OPTRAPOL NG REFILLS
Lot or serial number
VL0843
Model or catalog number
634459
Companies
- Manufacturer
-
Ivoclar Vivadent AG
Bendererstrasse #2
Schaan
9494
LIECHTENSTEIN