| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00131-1 |
| Product Name/Description |
Trinity Acetabular Shell
Multiple Part Numbers affected
Multiple Lot Codes affected
ARTG Number: 235377 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
There is potential for abrasion of the sterile barrier pouches of the new packaging system which was introduced in November 2015. If this failure was to occur, it could potentially render the product non-sterile.
There have been no product complaints received about this issue to date. |
| Recall Action |
Recall |
| Recall Action Instructions |
Corin is advising users to return all affected product. Product will be replaced with stock packaged in the previous packaging system.
This action has been closed-out on 21/03/2018. |
| Contact Information |
02 9497 7432 - Corin |