Events

Recall of Smith & Nephew Echelon Hip System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Smith & Nephew Inc.

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
    16672
  • Event Initiated Date
    2014-05-08
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Smith & Nephew Surgical Ltd, Unit A 36 Hillside road, Wairau Valley, AUCKLAND 0760
  • Reason
    Smith & nephew surgical pty ltd has reported seven (n=7) medical device incident reports (mdir) of femoral stem component breakages. in all cases, the results of smith & nephew's investigations cited poor proximal bone support as a possible cause of implant failure., as a result of these investigations and smith & nephew's health hazard evaluation of this failure mode, the echelon surgical technique has been revised to reflect advice provided in the device instructions for use (ifu).
  • Action
    Instructions for use to be updated

Device

Smith & Nephew Echelon Hip System

Manufacturer

Smith & Nephew Inc