Events

Recall of GYROS cups without legs

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 Depuy.

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
    2007-02-15
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-cupules-gyros-sans-patte
  • 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
    The company Depuy France has withdrawn from the market on February 14, 2007 all batches of number less than 2061791 of the medical device called "cup GYROS without tab" references L47558, L47560, L47562, L47564, L47566, L47568 used in orthopedics: hip prosthesis, due to a lack of sphericity of some GYROS cups without tabs that could cause a blockage of the polyethylene insert. The company has directly notified the recipients of the incriminated lots with the enclosed message (14/02/2007) (28 KB) validated by Afssaps. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance and to the block supervisors for diffusion, if necessary to the services concerned.

Device

GYROS cups without legs
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Depuy

Manufacturer

Depuy