Events

Recall of ABGII Modular Stems and ABGII Modular Necks (An exchangeable modular neck, designed to allow intra-operative flexibility for bio mechanical adjustment of offset and anteversion without affecting leg length)

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-00493-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-07-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00493-3
  • 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
    This action is occurring worldwide because of a high incidence of wear, known as fretting and corrosion, at the join between the femoral stem and the neck component. fretting and corrosion can result in metal debris in and around the hip joint. if this occurs, patients may experience inflammation, adverse local tissue reactions (altrs), hypersensitivity/allergic reactions and osteolysis (bone loss).
  • Action
    The ABGII Modular Femoral Stem and Modular Neck has been cancelled from the Australian Register of Therapeutic Goods (ARTG). Stryker Australia Pty Ltd has contacted orthopaedic surgeons who has ever implanted the ABGII modular hip replacement system. Those surgeons have been asked to contact their patients to discuss what clinical action is most appropriate. For more details, please see https://www.tga.gov.au/alert/abgii-modular-femoral-stem-and-modular-neck-hip-replacement-system and https://www.tga.gov.au/alert/abgii-modular-femoral-stem-and-modular-neck-hip-replacement-system-update .

Device

ABGII Modular Stems and ABGII Modular Necks (An exchangeable modular neck, designed to allow intr...
  • Model / Serial
    ABGII Modular Stems and ABGII Modular Necks (An exchangeable modular neck, designed to allow intra-operative flexibility for bio mechanical adjustment of offset and anteversion without affecting leg length) Multiple Catalogue NumbersAll lot numbersARTG Number: 145647
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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