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Bellatek Zirconia Abutments (2013-09-03)
- Starting date:
- September 3, 2013
- Posting date:
- September 27, 2013
- 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-35913
Recalled products
- Bellatek Zirconia Abutments
- Bellatek Zirconia Abutments - Lab Designed
Reason
The product is experiencing a fracture rate in which prior corrective actions have been ineffective in mitigating. In addition to recalling the product, the manufacturer has ceased distribution of the subject product.
Affected products
A. Bellatek Zirconia Abutments
Lot or serial number
Lots from 2011/04/01 to present
Model or catalog number
- EDAZ
Companies
- Manufacturer
-
Biomet 3I
4555 Riverside Drive
Palm Beach Gardens
33410
Florida
UNITED STATES
B. Bellatek Zirconia Abutments - Lab Designed
Lot or serial number
Lots from 2011/04/01 to present
Model or catalog number
- EDAZX
Companies
- Manufacturer
-
Biomet 3I
4555 Riverside Drive
Palm Beach Gardens
33410
Florida
UNITED STATES