Events

Recall of Reflection Deadblow Mallet

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smith & Nephew Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00301-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00301-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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.

Device

Reflection Deadblow Mallet
  • Model / Serial
    Reflection Deadblow MalletModel Number: 71362106All Batch NumbersARTG Number: 104373
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd