Events

Recall of Triathlon CR/PS Inserts & ASYM Patella, Brunswik Captive Cemented Cup, Avon Patella Medium & Patella Femoral Joint, HMRS Humerus Bearing, MRH Bumper Neutral/3 Degrees & Tibial Inserts, Scorpio CR Tibial Insert & Medialised Patella, Duracon PCA Femoral, Patella & Constrain Inserts, Scorpio PS Tibial & Flex PS/+PS/+PCS Inserts (total knee, hip, shoulder components) and Artisan Bone Plug

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker Australia 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-2012-RN-01003-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-10-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01003-1
  • 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
    Stryker orthopaedics has become aware of a potential packaging issue associated with various products, potentially affecting sterility of the devices.
  • Action
    Quarantine the affected devices identified in customer letter from Stryker.

Device

Triathlon CR/PS Inserts & ASYM Patella, Brunswik Captive Cemented Cup, Avon Patella Medium & Pate...
  • Model / Serial
    Triathlon CR/PS Inserts & ASYM Patella, Brunswik Captive Cemented Cup, Avon Patella Medium & Patella Femoral Joint, HMRS Humerus Bearing, MRH Bumper Neutral/3 Degrees & Tibial Inserts, Scorpio CR Tibial Insert & Medialised Patella, Duracon PCA Femoral, Patella & Constrain Inserts, Scorpio PS Tibial & Flex PS/+PS/+PCS Inserts (total knee, hip, shoulder components) and Artisan Bone PlugMultiple item and lot numbersARTG:128028, 139146, 128021, 128026, 139145, 145124, 128448, 141151 & 142278
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA