Events

Recall of RECLAIM Distal Stem with Taper Sleeve Protector (Press-fit hip femur prosthesis)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd T/A Depuy Australia.

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-2014-RN-00717-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00717-1
  • 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
    Johnson & johnson medical pty. ltd (jjm) is notifying surgeons of a change to the surgical procedure for all lots of reclaim taper sleeve protector because the product can be difficult to remove from the distal stem both before surgery and after proximal reaming.
  • Action
    Johnson & Johnson Medical is advising surgeons to remove the Taper Sleeve Protector prior to implantation of the RECLAIM Distal Stem. JJM will remove the Taper Sleeve Protector from future Distal Stems.

Device

RECLAIM Distal Stem with Taper Sleeve Protector (Press-fit hip femur prosthesis)

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia