Events

Recall of MENTOR Gel Sizers (Sizer for mammary 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.

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-00600-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-06-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00600-1
  • 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
    A complaint was received for a volume discrepancy between the pad print (500cc) and laser engraved marking and all other product labelling (550cc) on a mentor gel sizer manufactured at mentor leiden. during the bounding investigation, a second lot was identified as having a style discrepancy between pad print (moderate profile, mp) and all other product labelling (moderate plus, m+). misjudging the size or style of an implant can result in asymmetric outcome, which may need additional surgery.
  • Action
    Johnson & Johnson Medical (JJM) is requesting their customers to quarantine the affected stock immediately. Arrangements to return the product can be made by contacting the JJM customer service.

Device

MENTOR Gel Sizers (Sizer for mammary prosthesis)
  • Model / Serial
    MENTOR Gel Sizers (Sizer for mammary prosthesis)Product Code: RSZ5501 Lot Number: 6680501Product Code: RSZ2751Lot Number: 6749298ARTG Number: 157489
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd