| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01102-1 |
| Product Name/Description |
SynReam Medullary Reamer Head Ø 8.5 mm (part of the Adolescent Lateral Femoral Nail and SynReam Reaming System Instrument Trays)
Lot Numbers: 20141 to 24510, 15932 to 19396, 24613 to 25347 and 1448284 to 2087630
ARTG Number: 153666 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential risk of intraoperative reamer head breakages resulting in un-retrieved fragments of non-implant grade material in the surgical site. |
| Recall Action |
Recall |
| Recall Action Instructions |
Depuy Synthes is advising users to inspect SynReam Sets for the affected lots and return to Synthes for replacement with unaffected stock. |
| Contact Information |
1800 796 8437 - Synthes Australia |