| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00559-1 |
| Product Name/Description |
Affixus Hip Fracture Nail
Multiple Item Numbers
ARTG Number: 212235 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer Biomet has identified an issue with the Affixus Hip Fracture Nail not properly engaging with the targeting jig. An investigation into the nail/targeting jig assembly showed that certain specifications were undersized causing interference to the fit of the nail onto the targeting jig which can result in a surgical delay. |
| Recall Action |
Recall |
| Recall Action Instructions |
Users are asked to:-
1. Review the notification and ensure affected personnel are aware of the contents;
2. Quarantine all affected product for collection by your Zimmer Biomet sales representative;
3. Complete and return the acknowledgement form as per the instructions in the customer letter; and
4. Notify Zimmer Biomet of any adverse events associated with this device.
This action has been closed-out on 21/03/2018. |
| Contact Information |
02 9483 5426 - Zimmer Biomet |