Reflection Deadblow Mallet 의 리콜

Recall

RC-2017-RN-00301-1

Class II

2017-03-01

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00301-1

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.

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.