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LAVA Ultimate Restoratives (2015-06-15)
- Starting date:
- June 15, 2015
- Posting date:
- July 7, 2015
- 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-54090
Recalled Product
- LAVA ULTIMATE CAD/CAM RESTORATIVE
- LAVA ULTIMATE IMPLANT CROWN RESTORATIVE
Reason
Approximately 10% of dental accounts have reported to 3M that Lava Ultimate Crowns de-bonded at a rate higher than their typical experience for crowns. The reported de-bond rates varied greatly and often significantly exceeded the 2-4% rates generally reported in clinical literature. Based on this customer feedback, the product is not meeting performance expectations for consistent and predictable outcomes for the crown indication.
Affected products
A.LAVA ULTIMATE CAD/CAM RESTORATIVE
Lot or serial number
ALL
Model or catalog number
ALL
Companies
- Manufacturer
-
3M ESPE Dental Products
2510 Conway Avenue
St. Paul
Minnesota
UNITED STATES
B.LAVA ULTIMATE IMPLANT CROWN RESTORATIVE
Lot or serial number
ALL
Model or catalog number
ALL
Companies
- Manufacturer
-
3M ESPE Dental Products
2510 Conway Avenue
St. Paul
Minnesota
UNITED STATES