Events

Recall of Milestone Wand STA Hand Piece model STA-5050-305

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Henry Schein Halas.

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-00578-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-07-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00578-1
  • 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
    Wand hand piece model wa-2050-305 was packaged (pouched) and boxed as a wand sta hand piece model sta-5050-305. although the function of the hand pieces are identical, these hand pieces are used in two different instruments and they will only attach into the correct instrument.
  • Action
    Milestone is requesting the customers to inspect the inventory of the Wand Handpieces by looking at the cartridge holder locking tab without opening the sterile pouch. If any mislabelled handpieces are identified, Milestone is requesting the customers to contact Milestone Customer Service to obtain return authorisation and / or replacement of the handpieces. Milestone is also instructing the customers that they can also return the entire quantity of the affected STA Handpieces. This action has been closed-out on 31/08/2016.

Device

Milestone Wand STA Hand Piece model STA-5050-305
  • Model / Serial
    Milestone Wand STA Hand Piece model STA-5050-305 Batch or Lot number:140103Expiry date: January 2019ARTG Number: 95633
  • Manufacturer
    Henry Schein Halas

Manufacturer

Henry Schein Halas