Recall of Smith & Nephew Birmingham Hip Modular Head (BHMH), monoblock version

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Smith & Nephew Orthopaedics 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
    19520
  • Event Initiated Date
    2015-12-23
  • Event Country
  • Event Source
    NZMMDSA
  • Event Source URL
  • 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
    Data from the australian orthopaedic association's national joint replacement registry and the national joint registry for england, wales and northern ireland indicates the revision rate is above the uk's national institute health and carte excellence (nice) benchmark.
  • Action
    Manufacturer to issue advice regarding use

Device

  • Model / Serial
    Model: 74121238, 74121242, 74121246, 74121250, 74121254, 74121258, 74121338, 74121342, 74121346, 74121350, 74121354, 74121358, 74121438, 74121442, 74121446, 74121450, 74121454, 74121458, 74121538, 74121542, 74121546, 74121550, 74121554, 74121558, Affected: All lots
  • Manufacturer

Manufacturer