Events

Recall of Biolox Forte 36mm Alumina Ceramic Head Ceramic Femoral Head 36mm SLT Taper Short Neck

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Surgical Specialties 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-2017-RN-00233-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00233-1
  • 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
    An investigation was completed following a complaint by a surgeon that the ceramic femoral head was shorter by 2mm than other 36mm microport femoral heads. microport's investigation confirmed this complaint and concluded that the microport 36mm ceramic femoral heads have been manufactured to this specification for over 15 years. the main complaint issue associated with this finding would be surgical revision for dislocation or laxity of the hip joint.
  • Action
    Surgical Specialties is advising surgeons to maintain their usual follow-up protocol and actions for their patients and to ensure that these patients are informed about symptoms (particularly pain, instability, difficulty walking and/or performing common tasks) that indicate the need for revision surgery.

Device

Biolox Forte 36mm Alumina Ceramic Head Ceramic Femoral Head 36mm SLT Taper Short Neck
  • Model / Serial
    Biolox Forte 36mm Alumina Ceramic Head Ceramic Femoral Head 36mm SLT Taper Short NeckPart Number: 26000010 Ceramic Femoral Head 36mm SLT Taper Medium NeckPart Number: 26000011Ceramic Femoral Head 36mm SLT Taper Long NeckPart Number: 26000012
  • Manufacturer
    Surgical Specialties Pty Ltd

Manufacturer

Surgical Specialties Pty Ltd