| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00202-1 |
| Product Name/Description |
Transpedicular Schanz Screw, 6.2mm with dual core, length 190/45mm. Titanium alloy (TAN), dark blue (Bone screw for internal spinal fixation system)
Part Number: 496.723
Lot Number: 8123409
ARTG Number: 133401 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
Complaints have been received that advise that the fracture clamp could not be used with the affected screws because the end of the screws were manufactured out of specification (too thick). |
| Recall Action |
Recall |
| Recall Action Instructions |
Hospitals are being requested to inspect inventory, isolate any affected lot lots and return any items to Synthes Australia. |
| Contact Information |
1800 796 843 7 - Customer Service |