Events

Recall of SIGMA Fixed Bearing Tibial Inserts - PLI, Cruciate Retaining, Posterior Stablised (used as part of SIGMA Knee System)

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-2013-RN-00799-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-08-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00799-1
  • 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 compatibility chart on the product label and or reference chart literature/poster indicates that the size 6 posterior stabilized (ps) femoral component is compatible with the size 4 posterior stabilized (ps) tibial inserts and size 4 stabilized plus (sp) tibial inserts. the size 6 ps femoral component is not cleared for use with the size 4 posterior stabilized (ps) tibial inserts and size 4 stabilized plus (sp) tibial inserts, and should not be implanted with either of these size 4 insert.
  • Action
    Existing OR Reference Charts on posters should be discarded and replaced with revised OR Reference Charts, which will be supplied to the customers by JJM sales representatives.

Device

SIGMA Fixed Bearing Tibial Inserts - PLI, Cruciate Retaining, Posterior Stablised (used as part o...
  • Model / Serial
    SIGMA Fixed Bearing Tibial Inserts - PLI, Cruciate Retaining, Posterior Stablised (used as part of SIGMA Knee System)Multiple model numbers affectedAll lots manufactured after July 2010ARTG Numbers: 138289, 98092
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia