Events

Recall of Stryker Instruments Heavy Duty Sagittal Blade 18x0.97x90mm (used to cut bone and bone related tissue in orthopaedic procedures)

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-01114-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01114-1
  • 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
    For a small portion of the affected lot, the seal between the top and base rollstock material of the product packaging may not have been manufactured correctly resulting in a sterile barrier breach. due to this breach in sterility, there is a potential for a bone or soft tissue infection which may require medical or surgical intervention.
  • Action
    Stryker is advising users to inspect inventory for the affected lots and quarantine immediately. Affected stock can be returned to Stryker for replacement with unaffected product. This action has been closed-out on 10/05/2017.

Device

Stryker Instruments Heavy Duty Sagittal Blade 18x0.97x90mm (used to cut bone and bone related tis...
  • Model / Serial
    Stryker Instruments Heavy Duty Sagittal Blade 18x0.97x90mm (used to cut bone and bone related tissue in orthopaedic procedures)Item Number: 6118-097-090Lot Number: 16029017ARTG Number: 140542
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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