| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00502-1 |
| Product Name/Description |
NDI Disposable Reflective Marker Spheres
(reflective marker spheres for use with Brainlab image-guided surgery systems)
Lot C102061501
ARTG Number: 182255 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
NDI determined that DRMS spheres from Lot C102061501 may break apart at the mid-point where the two halves of the sphere are sealed
together, either during installation onto reference arrays or surgical tools (i.e., when threading them onto posts), or any time during a surgical procedure.
One failure of this nature has been reported, with no report of injury or death. |
| Recall Action |
Recall |
| Recall Action Instructions |
Life Healthcare is requesting their customers to quarantine any affected stock. Life Healthcare will provide replacement stock where required. This action has been closed-out on 10/08/2016. |
| Contact Information |
1800 060 168 - Life Healthcare |