Type of Product |
Medical Device |
TGA Recall Reference |
RC-2014-RN-01222-1 |
Product Name/Description |
3i T3, Full Osseotite Tapered & Parallel Walled Dental Implants
3i T3 Non-Platform Switched Tapered Implant 3.25X8.5 -15.0mm Catalog Number BOST3211 Lot Numbers: 2014051395 (Expiry: 12/11/2018), 2014051817 (Expiry: 12/09/2018)
Full Osseotite Certain Implant 3.25X8.5 - 15.0mm Catalog Number XIFNT3211 Lot Number 2014051477 (Expiry: 12/06/2018)
Parallel Walled Certain 2 Implant 3.25X8.5 - 18mm Catalog Number: XIFOSM311 Lot Number: 2014051368 (Expiry: 12/03/2018)
ARTG Number100482 |
Recall Action Level |
Retail |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
2/12/2014 |
Responsible Entity |
|
Reason/Issue |
BIOMET 3i has identified a visually observable condition which may be present on a limited number of the identified implants. The condition is caused by the implant coming into contact with residual machining fluid which was not adequately degreased from a portion of 1 lot of packaging cylinders. The residual machining fluid causes the implants to be discoloured. BIOMET 3i has determined that there are no known health effects of the residue. This has been confirmed through Cytotoxicity and Endotoxicity tests, which have yielded negative results for toxins on residue-affected samples. |
Recall Action |
Recall |
Recall Action Instructions |
No affected units are known to have been implanted in Australia. Customers are advised to return affected products to BIOMET 3i Australia Pty Ltd for replacement with unaffected units. This action has been closed-out on 14/07/2016. |
Contact Information |
1800 342 5454 - Biomet 3i Australia Pty Ltd |