| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01241-1 |
| Product Name/Description |
Synream Medullary Reamer Head Size 13.5mm
Part Number: 352.135
Lot Number: F1-17180
ARTG Number: 153666 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
The affected part number and lot number is etched as dimension 13.5mm while the actual dimension is 14mm.
If a 14mm reamer head is labelled and etched as a 13.5mm, there is the potential that the surgeon would be advancing 1.0mm versus 0.5mm; thus, there is a risk of the reamer head jamming. Surgical delay could occur as the reamer head is removed from the medullary canal and bone debris is removed or the reamer head is replaced with another reamer head. There is also the potential for damage to the bone. |
| Recall Action |
Recall |
| Recall Action Instructions |
JJM is advising users to inspect stock and return any of the affected product to JJM for replacement with unaffected stock. This action has been closed-out on 24/08/2016. |
| Contact Information |
1300 562 711 - Customer Service |