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All batches of Reflection’s dead blow mallets are to be quarantined and returned to the manufacturer due to lead beads escaping into surgical wounds.

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All of the dead blow mallet hammers manufactured by Smith and Nephew have been recalled after reports of broken mallet heads were made.

The dead blow mallets are different to conventional hammers as they are made to apply more precise pressure and less damage to the surface struck. The minimal elastic rebound is usually created by leaving the hammer head hollow or filled with loose sand, steel beads, or lead beads. However, this means that, if they break or crack, the filling could spill out, and this has resulted in the recall.

Smith and Nephew have been providing health institutes with dead blow mallets since 1995. Medical professionals use these hammers mainly for hip replacement surgery during broaching and when inserting the hip implants. In the reported cases, the hammer’s welding cracked, and the lead beads fell into the open surgical wounds.

Needless to say, exposure to lead is a health hazard.

The dangers of lead

Overexposure to lead can cause attacks to the brain and central nervous system. This in turn can result in convulsions, comas, and even death.

Young children with severe lead poisoning have been known to have mental retardation and behavioural disorders; if they survive the poisoning. However, this is seemingly limited to hip replacement surgeries, so it appears unlikely that any children have been affected. Since the incidents happened during surgery, medical operatives were able to remove the lead beads, and no further adverse effects have so far been reported. Nevertheless, the exposure to the patient and the staff is not to be ignored.

Recalls issued

Smith and Nephew have rightly issued a Field Safety Notice and a list of actions for institutes currently possessing the reportedly dangerous hammers. The Gov.uk website has issued the medical device alert and list of steps for institutes and staff to action:

  • Be aware and read the Safety Notice;
  • Locate and quarantine all batches immediately;
  • Return quarantined products to the manufacturer;
  • Complete the return slip as requested by the manufacturer;
  • Contact the manufacturer to arrange for an alternative device.

It is believed that the standard surgical device is used by not only by NHS hospitals but also independent and private hospitals. All relevant staff are to be notified.

The content of this post/page was considered accurate at the time of the original posting and/or at the time of any posted revision. The content of this page may, therefore, be out of date. The information contained within this page does not constitute legal advice. Any reliance you place on the information contained within this page is done so at your own risk.
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First published by Admin on April 17, 2017
Posted in the following categories: Recalls


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