Events

Recall of Tibial Implants

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Tornier 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-00008-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-01-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00008-1
  • 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
    During a routine surveillance control of tibial implants provided by the manufacturer’s supplier, some parts were discovered not conform on dimensional aspect, which could compromise adequate assembly between the polyethylene insert and the tibial component.
  • Action
    Locate and quarantine the affected devices, Complete the supplied form to confirm receipt of the recall notification. The sponsor will contact customers to arrange the return and exchange of affected units.

Device

Tibial Implants
  • Model / Serial
    Tibial ImplantsTibial Implant Size1Ref. LJU521Lots # AB3688 – AB5151 – AB4979Tibial Implant Size 2Ref.: LJU522Lot # AB3087ARTG 134055
  • Manufacturer
    Tornier Pty Ltd

Manufacturer

Tornier Pty Ltd