| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01208-1 |
| Product Name/Description |
Multiple dental abutment products and their accessories.
Multiple Item Numbers affected with expiration dates between November 2015 and November 2020.
ARTG: 120288 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
An investigation has determined that a limited number of product pouches may not have been sealed during packaging (occurrence rate 0.008%). In the event that a product pouch is unsealed, the sterility of the product contained within the pouch cannot be assured and may lead to infections or the product may be missing. |
| Recall Action |
Recall |
| Recall Action Instructions |
The sponsor is advising users to inspect stock and quarantine units from the affected lots regardless of whether a packaging seal can be visualised prior to their return to the sponsor. This action has been closed-out on 29/08/2016. |
| Contact Information |
1800 802 457 - Biomet 3i |