| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00338-1 |
| Product Name/Description |
Flexible Handle for Simplified Universal Nail System (SUN) and the Universal Nail System (UNI) (Re-usable surgical instrument supplied as part of internal fixation system implantation kit)
Flexible Handle Part Number: 355.280
ARTG Number: 153950 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
23/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has identified that there is a potential lack of the ability to thoroughly clean the instrument. |
| Recall Action |
Recall |
| Recall Action Instructions |
The affected handle is being recalled and replaced with a new design of handle. |
| Contact Information |
02 9855 4620 - Synthes Australia |