Events

Recall of BIOLOX delta ceramic components Biolox Delta Modular Head and Trinity Ceramic Liner

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Corin Australia 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-01518-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01518-1
  • 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
    Data from sources external to corin suggest that ceramic fragments from fractured ceramic components may remain in the joint following revision surgery, which can lead to premature wear of revision components if such revision components are made of non-ceramic materials. as a result, the instruction within the ifu for corin’s biolox delta ceramic components have been updated in respect of recommended actions in the case of revisions.
  • Action
    The IFU is being revised to include the following information in the ‘Warnings & Precautions’ section: In the case of revision due to a fractured ceramic component, when keeping a well fixed stem, the modular head must be replaced with a Biolox Option modular head where available. If a Biolox Option modular head is not available, in addition to revising the modular head, the femoral stem must also be revised to provide a suitable taper to which a new ceramic femoral ball head can be attached. In the event of revision not due to fracture of a ceramic component, when keeping a well fixed stem, the modular head must be replaced with a metal modular head or a Biolox Option ceramic modular head only.

Device

BIOLOX delta ceramic components Biolox Delta Modular Head and Trinity Ceramic Liner
  • Model / Serial
    BIOLOX delta ceramic componentsBiolox Delta Modular Head and Trinity Ceramic LinerAll Part Number / Lot Codes ARTG Numbers: 211371 and 210774
  • Manufacturer
    Corin Australia Pty Ltd

Manufacturer

Corin Australia Pty Ltd