Events

Recall of Confidence Spinal Cement System 11cc Plus Kit, Confidence Spinal Cement System KitAll lot numbers affected

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical 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-2013-RN-00068-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-01-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00068-1
  • 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 cement mixer used to prepare cement for surgery has been identified to not turn properly. the event may be described as the mixer being 'jammed' or 'stuck' and not able to turn, which could result in surgical delay in order to prepare another kit, or the inability to complete the procedure if an additional kit is not available; thereby exposing the patient to additional anaesthesia in another surgical procedure.
  • Action
    Customers are being advised to quarantine any affected products and return the products for a credit.

Device

Confidence Spinal Cement System 11cc Plus Kit, Confidence Spinal Cement System KitAll lot numbers...
  • Model / Serial
    Confidence Spinal Cement System 11cc Plus Kit, Confidence Spinal Cement System KitAll lot numbers affectedProduct Codes: 283910000 and 283913000
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd