| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01137-1 |
| Product Name/Description |
Micro Curved Attachment (MCA) and MCA Cutting Burrs (Intended for use in delicate bone in otologic (ear) procedures such as cochleostomy)
Multiple Part Numbers
All Lot Numbers
ARTG Number: 141597 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
It has been determined that the current directions for use for the Micro Curved Attachment (MCA) and MCA cutting burrs do not provide clear indication for use specifically for the MCA burrs. The use of the device in dense bone removal may result in cutter fracture. |
| Recall Action |
Recall |
| Recall Action Instructions |
Quarantine and return affected devices to Synthes Australia. |
| Contact Information |
1800 7968437 - Customer Service |