| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01134-1 |
| Product Name/Description |
Star Drive Frame Adapters and Positioners (intended to be used with stereotactic systems for neurosurgical procedures for accurate positioning of mircoelectrodes, stimulating electrodes or other instruments in the brain or nervous system)
Model Numbers: 70-LG-01, 70-FA-RD, 70-FA-LX
Serial Numbers: 10205, 00001, 00002, 126279, 126314
ARTG Number: 177545 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, FHC Inc, has received two reports where the 5-hole metal insert of the frame adapter or positioner became loose. In both instances, the insert did not fall completely out of metal housing but loosened within the adapter. Neither event resulted in patient injury. Such looseness may result in a slight axial movement of the insert although FHC has not identified any significant patient risk as a result of this movement. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are advised to contact Emergo Australia to arrange for the return of affected devices to the manufacturer, FHC Inc, for repair. There are loan kits available for use until the devices are corrected. |
| Contact Information |
02 9006 1662 - Emergo Australia |