Events

Recall of Score Extension Stem for Total Knee Prosthesis - Cemented

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-00706-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00706-1
  • 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
    Amplitude has become aware through transport simulation tests that the packaging pouches of some devices could be damaged. the pouches function as the sterile barrier of the device packaging. there is a risk of infection if a patient is implanted with a non- sterile implant. the implantation of non-sterile device is unlikely. the routine tests conducted on devices did not show any case of non-sterility and no clinical incident was reported in relation with loss of sterility of the device.
  • Action
    Amplitude is advising users to inspect stock and quarantine any remaining units of the affected products for return. Patients with implanted devices should be followed up as per standard hospital procedures.

Device

Score Extension Stem for Total Knee Prosthesis - Cemented
  • Model / Serial
    Score Extension Stem for Total Knee Prosthesis - CementedMultiple product codes affectedAll lot numbers affectedARTG number: 242001
  • Manufacturer
    Amplitude Australia Pty Ltd

Manufacturer

Amplitude Australia Pty Ltd