| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00500-1 |
| Product Name/Description |
Medtronic Navigation Sterile Devices (used in a variety of imaged guided, navigated surgical procedures)
Multiple part numbers and lot numbers affected
ARTG Numbers: 98905, 118232, 119035, 119881, 122416, 123340, 126293, 129428, 165744 & 196655 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
A review of the Medtronic internal returned goods procedures showed that there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage. Although there have been no reports of issues related to package sterile barrier damage, Medtronic is recalling all potentially affected devices as a precaution. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers will be contacted by a Medtronic representative who will make arrangements visit the facility for the collection and return of any of the affected products, as appropriate. During this visit, Medtronic will arrange to replace the goods free of charge. This action has been closed-out on 11/02/2016. |
| Contact Information |
02 9857 9179 - Medtronic Regulatory Affairs |