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IPS E.max Ceram restorations.(2015-07-27)
- Starting date:
- July 27, 2015
- Posting date:
- August 11, 2015
- 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-54626
Affected Products
- IPS E.MAX CERAM GLAZE PASTE REFILL
- IPS E.MAX CERAM GLAZE POWDER REFILL
- IPS E.MAX CAD-ON SYSTEM CRYSTALL / CONNECT
Reason
A number of complaints were received with the issue of coarse particles in the glazed surface of IPS E.max Ceram restorations.
Affected products
A. IPS E.MAX CERAM GLAZE PASTE REFILL
Lot or serial number
- U01578
- U09829
- U15900
Model or catalog number
- 597042
Companies
- Manufacturer
-
Ivoclar Vivadent AG
Bendererstrasse #2
Schaan
9494
LIECHTENSTEIN
B. IPS E.MAX CERAM GLAZE POWDER REFILL
Lot or serial number
- T43549
Model or catalog number
- 597044
Companies
- Manufacturer
-
Ivoclar Vivadent AG
Bendererstrasse #2
Schaan
9494
LIECHTENSTEIN
C. IPS E.MAX CAD-ON SYSTEM CRYSTALL / CONNECT
Lot or serial number
- U09241
Model or catalog number
- 567761
Companies
- Manufacturer
-
Ivoclar Vivadent AG
Bendererstrasse #2
Schaan
9494
LIECHTENSTEIN