Events

Recall of TOPAZ MicroDebrider Wand (used for ablation and microdebridment in the tendons of the ankles, knees and shoulders)

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-00275-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00275-1
  • 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
    Topaz microdebrider wands has failed to meet shelf-life at the expiration date indicated on the product labels during internal functional testing. it has been found that saline may leak from the proximal end of the handle during use, and the spacer between the active and return electrodes may be displaced. this can potentially lead to the spacer being unintentionally retained in a patient, which may lead to a prolonged procedure time.
  • Action
    Smith & Nephew is advising users to discontinue use and return the affected product. Smith & Nephew will be able to provide users with alternate products. This action has been closed-out on 25/01/2017.

Device

TOPAZ MicroDebrider Wand (used for ablation and microdebridment in the tendons of the ankles, kne...
  • Model / Serial
    TOPAZ MicroDebrider Wand (used for ablation and microdebridment in the tendons of the ankles, knees and shoulders)Product Number: ACH4040-01All batches affectedARTG Number: 221504
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd