Events

Recall of Twinfix Quick-T Knot Pusher Suture Cutters

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smith & Nephew 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-00938-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00938-1
  • 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
    Smith & nephew have identified a packaging issue through internal testing. the twinfix quick-t knot pusher suture cutter could be subject to breaches of its sterile packaging. in the event the device is presented for use and a breach in the sterile barrier is not noticed, a non-sterile device could enter the surgical field. smith & nephew has received no customer complaints indicating a packaging breach or a post-operative infection.
  • Action
    Smith & Nephew is advising users to discontinue use of affected products and quarantine the device(s). The devices are to be returned to Smith & Nephew.

Device

Twinfix Quick-T Knot Pusher Suture Cutters
  • Model / Serial
    Twinfix Quick-T Knot Pusher Suture CuttersProduct Number: 7209417Batch Numbers: 50412843, 50477278, 50527184ARTG Number: 112714
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd