| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00939-1 |
| Product Name/Description |
Bellatek Zirconia Abutments
Encode Zirconia Designer Abutment
Product Part Numbers: EDAZ
LDA Encode Designed Zirconia Abutment
Product Part Numbers: EDAZX
ARTG Number: 120288 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/09/2013 |
| Responsible Entity |
|
| Reason/Issue |
Biomet 3i has received a number of reports relating to BellaTek Zirconia Abutment fractures. The device is fracturing at a higher than acceptable rate. |
| Recall Action |
Recall |
| Recall Action Instructions |
Affected customers are requested to return any BellaTek Zirconia Abutment cases to Biomet 3i for replacement with an alternative product or full credit. |
| Contact Information |
1800 802 457 - Biomet 3i Customer Service |