Events

Recall of Biolox Delta Ceramic Hip Components

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-2016-RN-01544-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01544-1
  • 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 is issuing this notification in relation to the ongoing use of all ceramic hip prostheses, including femoral ball heads and acetabular cup (shell) liners/ inserts that are either manufactured or distributed globally by smith & nephew. recent post-market surveillance suggests that ceramic fragments from fractured ceramic components of hip prostheses may remain in the joint during revision surgery, which may lead to premature wear in revision components if such revision components are made of non-ceramic materials. this may lead to a need for an additional revision surgery.
  • Action
    This notification has been issued by Smith & Nephew to caution against the use of non-ceramic components when revising fractured ceramic components used in hip arthroplasty and inform surgeons of changes to the warnings in Smith & Nephew Instructions for use (IFU). Additional information is provided in the letter to surgeons and the revised IFU.

Device

Biolox Delta Ceramic Hip Components
  • Model / Serial
    Biolox Delta Ceramic Hip ComponentsBiolox Delta Ceramic Femoral HeadARTG Number: 218138R3 Biolox Delta Ceramic LinerARTG Number: 218185 EP-FIT Biolox Delta Ceramic InsertARTG Number: 222565
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd