Events

Recall of MoPyc Radial Head Prosthesis Stem (used in elbow reconstruction)

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-2015-RN-01008-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01008-1
  • 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
    Tornier is informing users of the known risk potentially associated with over-expansion of the small-sized mopyc stem (ptr-s7) that can result in its postoperative fatigue fracture.Although the operating technique emphasises the fact that stem expansion should only be performed when rotation instability is observed in the shaft, tornier noticed that the stems which were subject to fracture were over-expanded. tornier is providing users with a surgical technique addendum to emphasise this key point of the operating technique and to avoid unnecessary stem expansion that may be harmful for the patient.
  • Action
    Tornier is providing users with a Surgical Technique Addendum to include further information regarding the risks of over expansion. This action has been closed-out on 25/08/2016.

Device

MoPyc Radial Head Prosthesis Stem (used in elbow reconstruction)
  • Model / Serial
    MoPyc Radial Head Prosthesis Stem (used in elbow reconstruction)All batches manufactured since 2011ARTG Number: 94231
  • Manufacturer
    Tornier Pty Ltd

Manufacturer

Tornier Pty Ltd