Events

Recall of QuikFlap Neuro Implants

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-2018-RN-00682-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-06-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00682-1
  • 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 current packaging and ifu indicate a five-year shelf life. during long-term product testing, it was discovered that after a three-year term, there is a potential for the external packaging (sterile barrier) to become compromised. such compromised packaging results in the loss of the vacuum seal allowing for contamination of the inside peel pouch. a breach of the outer peel pouch has only been observed with packages at shelf life end and after excessive transportation testing.To date, medtronic have not received any complaints as a result of this issue.
  • Action
    Stryker is advising customers to quarantine affected stock to prevent further use. Stryker representatives will contact customers to help coordinate the return of any affected product. In the event this device has been recently implanted, surgeons are advised to monitor for signs of infection as per their normal processes.

Device

QuikFlap Neuro Implants
  • Model / Serial
    QuikFlap Neuro ImplantsMultiple Item NumbersMultiple Lot Numbers ARTG Number: 295882(Stryker Australia - Cranofacial fixation plate, non-biodegradable)
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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