Events

Recall of "PROFEMUR R" PROX BODY PLASMA SPRAYSTD3 (femoral component of a hip joint prosthesis)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Wright Medical Australia 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-01062-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01062-1
  • 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
    The recall is being initiated because there is a label discrepancy that affects the shelf life listed on products manufactured at the toulon, france facility. the product functions as intended, however there is not adequate justification on file to support the packaging shelf life listed on the label. there have been no reported issues related to the packaging integrity or sterility of this product. this recall is being initiated because there is a potential risk to health (such as contamination/infection) that may arise if a packaging integrity failure were to occur.
  • Action
    Wright Medical advises devices implanted are considered safe and are not required to be revisited.

Device

"PROFEMUR R" PROX BODY PLASMA SPRAYSTD3 (femoral component of a hip joint prosthesis)
  • Model / Serial
    "PROFEMUR R" PROX BODY PLASMA SPRAYSTD3 (femoral component of a hip joint prosthesis)Product code: PPW38363Lot Number: X02382954ARTG Number: 154282
  • Manufacturer
    Wright Medical Australia Pty Ltd

Manufacturer

Wright Medical Australia Pty Ltd