| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00587-1 |
| Product Name/Description |
Aequalis IM Nail Targeting Jig
(Prosthetic joint implantation kit)
Lots: All lots - (DB0114069, DB0114349, CA46096, CA216052, DB0111264001, DB0112016, DB0113102)
Catalogue Number: 9020060
ARTG number: 177214 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
The targeting jig mast is separating from the jig boom. Any separation will impact alignment and can affect the ability to fixate the screws.
There has been no impact to a patient to-date; however, a design change to the product is necessary. |
| Recall Action |
Recall |
| Recall Action Instructions |
Tornier is developing a design change for the jig. Once the design change has been completed Tornier will arrange for the collection and replacement of the faulty devices. In the interim, Tornier has provided inspection instructions to ensure that faulty devices are not used in surgery.
This action has been closed out on 24/10/2018 |
| Contact Information |
02 9451 2244 - Wright |