Events

Recall of GENESIS II PS Articular Inserts (internal tibial component for knee prosthesis)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smith & Nephew Surgical 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-2013-RN-00912-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-08-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00912-1
  • 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 manufacturer has advised that the tyvek lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. during a total knee arthroplasty surgery, the user will most likely notice the inadequate seal and request another device.
  • Action
    Smith & Nephew is advising users to inspect products and quarantine affected devices. Affected devices will be replaced by Smith & Nephew.

Device

GENESIS II PS Articular Inserts (internal tibial component for knee prosthesis)
  • Model / Serial
    GENESIS II PS Articular Inserts (internal tibial component for knee prosthesis)GENESIS II PS Articular Insert Size 3-4 13mmCatalogue Number: 71420820Lot Number: 12GT20824GENESIS II PS High Flexion Insert Size 3-4 9mmCatalogue Number: 71421508Lot Number: 12GT20822ARTG Number: 114463
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd