| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00301-1 |
| Product Name/Description |
Reflection Deadblow Mallet
Model Number: 71362106
All Batch Numbers
ARTG Number: 104373 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
Smith & Nephew has received a small number of complaints reporting cracks in the welds located on the head of the mallet, which is filled with lead beads. In the reported cases some of the lead beads and particles escaped from the mallet into the surgical wound. As these failures occurred intra-operatively and appropriate actions were taken to remove the lead beads from the wound during surgery, no further adverse effects were reported. Smith & Nephew is recalling the mallets as the risk of lead escaping from the mallet and the potential adverse effects associated with lead exposure were previously unidentified risks. Based on the low occurrence (0.03%) of the worst case failure mode defined above and the high detectability should any lead beads escape into the surgical wound, no proactive follow-up is recommended. |
| Recall Action |
Recall |
| Recall Action Instructions |
Smith & Nephew are advising customers to immediately locate and quarantine affected devices. Smith & Nephew will arrange for the return of the devices and the provision of unaffected replacement mallets.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG |
| Contact Information |
02 9857 3918 - Smith & Nephew |