Events

Recall of Trident Constrained Liner Impactor Tips (Used for implantation of Trident Constrained Inserts during hip arthroplasty)

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-00808-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00808-1
  • 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 steam sterilisation validation with 3 half cycles (2 minutes, 132°c), it was identified that the trident constrained liner impactor tips do not meet the required sterility assurance level (sal) of 10-6.Please note that these instruments are sterilised at the hospital prior to surgery and are not distributed as sterile from stryker to customers. due to this inability to meet the sal, the instrument may be non-sterile and this could lead to a possible infection.
  • Action
    Stryker is advising users to inspect stock and quarantine any affected product for return. Stryker is providing information about alternative surgical methods of locking the insert into the shell. This action has been closed-out on 28/02/2018.

Device

Trident Constrained Liner Impactor Tips (Used for implantation of Trident Constrained Inserts dur...
  • Model / Serial
    Trident Constrained Liner Impactor Tips (Used for implantation of Trident Constrained Inserts during hip arthroplasty)Item Numbers: 21992022, 21992028, 21992032All Lot Numbers affectedARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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