| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00142-1 |
| Product Name/Description |
DVR ePAKs
All lots are affected
Multiple Part Numbers affected
ARTG Number: 210295 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
Iron oxidation has been found on components (mainly drill bits) contained in the DVR ePAKs.
A delay in surgery, less than 30 minutes may occur if surgical staff proceeds to re-sterilise the product or locate alternative products.
If oxidative material would flake off a component contained within the ePAK and enter the surgical field/wound, an inflammatory reaction may occur. The inflammatory reaction may result in a foreign body reaction and/or metal hypersensitivity. |
| Recall Action |
Recall |
| Recall Action Instructions |
Zimmer Biomet is advising users to quarantine affected stock for return to Zimmer. |
| Contact Information |
02 9483 5426 - Zimmer Biomet |