| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00938-1 |
| Product Name/Description |
Biomet 3i Dental Implants
Multiple models and lot numbers affected
ARTG Number: 100482 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/09/2013 |
| Responsible Entity |
|
| Reason/Issue |
Affected implants may look darker over some or the entire surface of the implant. This condition is caused by the implant coming into contact with residual machining fluid, which may have been left on the metal packaging insert. |
| Recall Action |
Recall |
| Recall Action Instructions |
Biomet 3i is requesting their customers to return any unused product for replacement. |
| Contact Information |
1800 802 457 - Biomet 3i |