Events

Recall of Cemented resurfacing patellar implant, Ø 33mm and 36mm

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Amplitude 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-01013-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01013-1
  • 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
    It has been reported to amplitude that sealing of some pouches is not as resistant as intended and could compromise their integrity, resulting in non-sterile devices. this may increase the risk of post-operative infection and may lead to an increased surgical time to locate an alternative device.
  • Action
    Amplitude is advising users to inspect stock and quarantine the affected batches for return. This action has been closed-out on 10/05/2017.

Device

Cemented resurfacing patellar implant, Ø 33mm and 36mm
  • Model / Serial
    Cemented resurfacing patellar implant, Ø 33mm and 36mmCemented resurfacing patellar implant - Ø 33mmReference Number: 1-0200833Batch Number: 236419Cemented resurfacing patellar implant - Ø 36mmReference Number: 1-0200836Batch Number: 236412ARTG Number: 216375
  • Manufacturer
    Amplitude Australia Pty Ltd

Manufacturer

Amplitude Australia Pty Ltd