Events

Recall of Stryker Laparoscopic Manual Instruments and Accessories

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-2014-RN-01264-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-12-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01264-1
  • 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 has identified that unacceptable validation reports were in place to support the unwrapped 10 minute, 132° (270°f) gravity steam sterilization cycle as well as the ethylene oxide (eo) sterilization cycle listed in instructions for use. this may give rise to cross infection as viable bacteria/ pathogens could be delivered to the subsequent patient. as a result the instructions for use (ifu) are being modified in a manner that these two sterilisation methods are being deleted and the remaining two options currently given (gravity wrapped & pre-vacuum wrapped methods) will remain in place.
  • Action
    The Gravity Unwrapped sterilization cycle and the Ethylene Oxide sterilization cycle have both been deleted as sterilisation options from the Instructions for Use (IFU1000-401-070), for Laparoscopic Instruments and Accessories. New instructions for use reflecting this deletion will be circulated to customers.The Gravity Wrapped and Pre-Vacuum Wrapped sterilisation methods will remain unchanged. This ation has been closed-out on 06/07/2016.

Device

Stryker Laparoscopic Manual Instruments and Accessories
  • Model / Serial
    Stryker Laparoscopic Manual Instruments and AccessoriesMultiple item numbers/ product descriptionsAll lotsARTG Numbers: 145845, 228398, 141250, 142780, 228395
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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