Events

Recall of Aequalis Ascend Flex Shoulder System PTC Humeral Stems

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Tornier 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-2017-RN-00860-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-07-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00860-1
  • 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
    Wright medical has identified a deviation of the manufacturing method for one lot of aequalis ascend flex shoulder system ptc humeral stems. this is a documentary discrepancy with regulatory impacts, but for which the patient risk was assessed as negligible.The subcontractor (who have manufactured the affected parts), used in fact the manufacturing method validated for tornier sas internal manufacturing, whereas the justification for the authorisation to use this method by the subcontractor, was insufficiently documented.
  • Action
    Measures to be taken by the customer: Wright Medical are asking that if any product is with customers, that they: 1. Locate and return parts; 2. Circulate this information to whom it may concern in the hospital; and 3. Inform a Tornier Representative of any adverse event.

Device

Aequalis Ascend Flex Shoulder System PTC Humeral Stems
  • Model / Serial
    Aequalis Ascend Flex Shoulder System PTC Humeral StemsReference Number: DWF602CLot Number: AA2028ARTG Number: 234030
  • Manufacturer
    Tornier Pty Ltd

Manufacturer

Tornier Pty Ltd