| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00354-1 |
| Product Name/Description |
Threaded Reduction Tool, 2.4mm diameter, self-drilling, 78mm length, with Hexagonal coupling
Part Number: 03.507.002S
Lot Number: 3632704
ARTG Number: 155807 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
The product for this particular lot (3632704) was distributed with "Not for Human Use" etched on the side of the tool. The etching was intended to indicate that the devices were for training purposes only. If the "Not for Human Use" etching on the Threaded Reduction Tool is discovered prior to its use on the patient, but in the operative theatre, it could lead to a small surgical delay until a replacement product is procured.
Synthes has advised that if the product was used in an operation, the Threaded Reduction Tool would work as intended and the patient would not be exposed to any increased risk. |
| Recall Action |
Recall |
| Recall Action Instructions |
End users are requested to immediately isolate any devices from the affected lot. Affected devices are to be returned to Synthes Australia. |
| Contact Information |
1800 796 8437 - Synthes Australia |