Events

Recall of ABGII Modular Modular Prosthesis Holes and Collars

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by STRYKER.

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
  • Date
    2012-07-23
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/tiges-et-cols-modulaires-abgii-modular-pour-prothese-totale-de-hanche-stryker-france-retrait-de-lots
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Extra notes in the data
  • Action
    On 20/06/2012, Stryker France sent ABGII Modular modular rod and collar users an information letter and follow-up recommendations for patients carrying these implants. . A recall of these implants was then decided and a second letter (23/07/2012) (39 ko) was sent to the users concerned on 24/07/2012. Read auss. ABGII Modular Modular Total Prosthesis Hose and Collars - Stryker UK - Safety Information (04/02/2013) ABGII Modular Modular Hip Prosthesis for sale - Stryker France - Safety Information (28/06/2012)

Device

ABGII Modular Modular Prosthesis Holes and Collars
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    STRYKER

Manufacturer

STRYKER
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    LAANSM