| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01018-1 |
| Product Name/Description |
TomoFix Plate Medial Tibia 4 Hole Standard and TomoFix Small Proximal Medial Tibia 4 Hole 112 mm Titanium Sterile
Part Numbers: 440.834S and 440.831S
ARTG Number: 157069 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
Following a customer complaint it has been determined that some information in the Surgical Technique Guide and Application Notes on the proximal screw angle and plate thickness is incorrect. A revision has been made to the Surgical Technique Guide and the Application Notes to correct this error. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Synthes is notifying hospitals of the error and is providing updated Surgical Technique Guides for users to follow. |
| Contact Information |
1800 796 843 - Synthes Australia |