Events

Recall of Twinfix Ultra Ti Suture Anchor, 5.5mm (used to attach the end or ends of a synthetic or natural ligament to bone)

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-2012-RN-00678-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-07-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00678-3
  • 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 manufacturer has advised that the distal part of the anchor may break on insertion into bone during surgery. the surgery may be completed using an alternative fixation device and, in most cases, the broken anchor can be retrieved with a grasper or sharp instrument.
  • Action
    Quarantine and return affected stock to Smith & Nephew Surgical for replacement.

Device

Twinfix Ultra Ti Suture Anchor, 5.5mm (used to attach the end or ends of a synthetic or natural l...
  • Model / Serial
    Twinfix Ultra Ti Suture Anchor, 5.5mm (used to attach the end or ends of a synthetic or natural ligament to bone)Catalogue Numbers: 72202618 & 72202895Multiple lot numbersARTG Number: 109451
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd