| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00420-1 |
| Product Name/Description |
Soft Tissue Retractor, small, extendible
Part Number: 325.010
All Lot Numbers Affected |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
Synthes have received complaints about tip breakage and/or locking nut malfunction. There have been reports of retrieval of device fragments intraoperatively and delays in surgical procedures. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are requested to return all affect units to DePuy Synthes Australia for replacement units.
Synthes will implement a design change to improve the robustness of material of construct of the locking nut. |
| Contact Information |
1800 796 843 - Synthes Australia Customer Service |