Events

Recall of Scorpio Patella Clamp (used to hold the patella in place during the cementing process)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker 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-01063-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01063-1
  • 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
    Stryker orthopaedics has received four reports of disassociated components of the scorpio patella clamp. an investigation revealed that the press-fit specifications between the pins and either one or both clamping subcomponents were not met. no adverse patient consequences were reported. the instrument components, including pins and clamping subcomponents may potentially disassociate and fall into the wound intra-operatively, necessitating retrieval. as such, the potential harms may include: - complications associated with extended surgery time - inflammatory response - tissue damage - revision surgery to retrieve loose components.
  • Action
    Stryker is advising users to inspect stock and quarantine the whole tray immediately if the affected product is found. A Stryker representative will coordinate a replacement clamp or the return of the whole tray that the affected item is in and provide access to unaffected trays as required. This action has been closed-out on 18/05/2017.

Device

Scorpio Patella Clamp (used to hold the patella in place during the cementing process)
  • Model / Serial
    Scorpio Patella Clamp (used to hold the patella in place during the cementing process)Item Number: 3182-1000Tray Item Numbers: 31821000-T, 33023024-T, 80002017-T, 80106661-T, 8200TSX-TMultiple Lot Numbers affectedARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA