Events

Recall of Signature Ceramic Femoral Head

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Signature Orthopaedics 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-2018-RN-00091-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00091-1
  • 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
    Signature orthopaedics has been made aware that a 28 (s) femoral head was found labelled as a 32 (s) ceramic femoral head. investigation of production records confirmed that these batches may be mislabelled, with the packaged component's size not corresponding to the label.
  • Action
    Signature Orthopaedics is advising users to quarantine all stock of the affected lot numbers and return to the sponsor.

Device

Signature Ceramic Femoral Head
  • Model / Serial
    Signature Ceramic Femoral HeadCatalogue Number: 111-152-624Batch Numbers: 78560, 78528Manufacture Date: 31/10/2017Expiry Date: 31/10/2022ARTG Number: 272595
  • Manufacturer
    Signature Orthopaedics Pty Ltd

Manufacturer

Signature Orthopaedics Pty Ltd