| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00510-1 |
| Product Name/Description |
Various ZNN & M/DN Guide Wires
Item Numbers: 00-2228-024-00, 47-2237-037-00, 47-2237-038-00, 47-2255-008-00, 47-2255-008-01, 47-2490-097-00 and 47-2490-098-00
Multiple Products and Lot Numbers
ARTG Numbers: 118540 and 112735 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer Biomet has identified specific lots of ZNN and M/DN Trauma Guide Wires may exhibit process monitoring failures related to the sterile seal on the packaging. A breach in the packaging seal could potentially lead to loss of sterility of the device.
To date, no complaints have been reported as a result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Zimmer Biomet is advising customers to identify and quarantine affected stock as necessary. Zimmer Biomet will contact users to remove any identified affected product and provide replacement.
This action has been closed out on 20/09/2018 |
| Contact Information |
02 9483 5400 - Zimmer Biomet |