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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 Smith & Nephew Pty Ltd
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.
Contact Information 02 9857 3918 - Smith & Nephew