| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01186-1 |
| Product Name/Description |
2.7mm Self-Tapping Cortex Screw (internal fixation device)
ASDM Part Numbers: 351-012, 351-014 & 341-016
Lot Numbers: 11164100, 11164200, 11164900 & 11165100
ARTG Number: 134456 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
Advanced Surgical Design & Manufacture Ltd, following a report of a fracture of the screw head during surgery, has determined that the affected products may be out of specification. |
| Recall Action |
Recall |
| Recall Action Instructions |
Advanced Surgical Design and Manufacture is asking customers to quarantine and return all affected devices for replacement stock. |
| Contact Information |
02 9439 4448 - Advanced Surgical Design and Manufacture Regulatory Affairs |