Events

Recall of DePuy Charnley Pin Retractor & Handle Set (orthopaedic hip joint replacement instrument)

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-00976-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-09-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00976-1
  • 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 issuing a device recall of the charnley pin retractor & handle set due to the potential for breakage of the small extraction peg away from the pin. analysis of the pegs from the above affected lots identified the existence of microscopic cracks in the weld region. this could lead to decreased strength and a greater risk of instrument fracture under what would be normally acceptable conditions.
  • Action
    Johnson & Johnson Medical Pty. Ltd. (JJM) is requesting the affected customer to inspect their inventory and quarantine the affected stock. JJM is making arrangements for a courier pick-up (free of charge) of the affected product and is issuing a credit note. This action has been closed-out on 07/06/2016.

Device

DePuy Charnley Pin Retractor & Handle Set (orthopaedic hip joint replacement instrument)

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia