Events

Safety Alert Or Field Safety Notices for Reflection® dead blow mallet (all batches)

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Smith & Nephew.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Date
    2017-02-17
  • Event Date Posted
    2017-02-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/reflection-dead-blow-mallet-all-batches-risk-of-exposure-to-lead-particles
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Manufactured by smith & nephew – cracking of the welds on the head of the mallet can result in lead particles escaping and entering the surgical wound, potentially resulting in effects associated with lead exposure.
  • Action
    Be aware of the manufacturer’s Field Safety Notice Locate and quarantine all batches immediately Return quarantined product to the manufacturer Complete the return slip as requested by the manufacturer Contact the manufacturer to arrange for an alternative device

Device

Reflection® dead blow mallet (all batches)

Manufacturer

Smith & Nephew
  • Manufacturer Address
    Greg Williams Smith & Nephew Tel: 01480 423 200Email greg.williams@smith-nephew.com
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    MHRA