| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01319-1 |
| Product Name/Description |
Depuy Synthes Trauma RIA (Reamer/Irrigator/Aspirator) system
Part Numbers: 352.260S and 351.718.02S
Multiple lot numbers affected
ARTG Number:157016 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
The expiration date on the label is incorrect. The affected sterile product components (comprising of a locking clip and a drive shaft seal packaged as separate parts) were labelled with expiration dates of 10 years rather than 2 years from the date of manufacturer. |
| Recall Action |
Recall |
| Recall Action Instructions |
Synthes is advising their customers to check inventory and to quarantine and return any affected units. This action has been closed-out on 07/07/2016. |
| Contact Information |
02 9855 4620 - Synthes Australia. This action has been closed-out on 07/07/2016. |