Events

Recall of Logical Ceramic Liner

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-2014-RN-00637-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-06-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00637-1
  • 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
    The affected devices have been mislabeled. the contents of the packaging does not match the identification on the label.This action was undertaken prior to notifying the tga.
  • Action
    Surgical orthopaedics requested their customer to return the affected lots. This action was undertaken without consulting with theTGA.

Device

Logical Ceramic Liner
  • Model / Serial
    Logical Ceramic LinerSerial Numbers: 111-22-1005 and 111-22-1007Lot Numbers: 7010864573 and 7010862871
  • Manufacturer
    Signature Orthopaedics Pty Ltd

Manufacturer

Signature Orthopaedics Pty Ltd