Events

Recall of ULTRA FAST-FIX Knot Pusher/Suture Cutter, Straight

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smith & Nephew Surgical 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-2015-RN-00406-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-05-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00406-1
  • 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 internal investigation found the packaging material and design to be insufficient to prevent the ultra fast-fix knot pusher suture cutter’s sharp edges from potentially puncturing the pouch and rendering the device unsterile. to date there have been no complaints or adverse effects associated with this issue.This could potentially lead to a post-operative infection.To date there have been no complaints or adverse effects associated with this issue.
  • Action
    Smith & Nephew is advising their customers to inspect the inventory and quarantine the affected devices immediately. A Smith & Nephew customer service representative will contact the customer to arrange collection of any affected products and advise on substitute devices available. This action has been closed-out on 11/08/2016.

Device

ULTRA FAST-FIX Knot Pusher/Suture Cutter, Straight
  • Model / Serial
    ULTRA FAST-FIX Knot Pusher/Suture Cutter, StraightProduct No: 72201537All batches manufactured from April 2010 to April 2014 which have corresponding expiration dates of April 2015 to April 2019ARTG Number: 112714
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd