| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00220-1 |
| Product Name/Description |
Medacta Femoral Stems
Lot/batch numbers: revision 13 and previous
ARTG Number: 204336 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
Following a report relating to the fracture of a stem neck, due to scratches made by the surgeon during a femoral head revision, Medacta has decided to modify the IFU of its hip implants. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medacta is providing their customers with updated instructions for use, advising surgeons of the potential for scratches on the neck of the femoral stems to impact on endurance of the stem. |
| Contact Information |
02 9420 2944 - Medacta Australia |