Events

Recall of GK sterile screws and S2

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
    2005-10-13
  • 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-vis-gk-et-s2-de-la-societe-stryker
  • 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 STRYKER removed from the market on October 10, 2005 all batches of the references specified in the recall message, the medical device called "GK sterile screws and S2" following a possible damage to the packaging. Units with a label on their outer packaging that says "QA approved" are not affected by this recall. These screws are used in traumatology .. The company has directly notified the recipients of the incriminated references with the message attached (10/10/2005) (16 KB) validated by Afssaps. This information is addressed to the directors of health establishments, pharmacists and local correspondents of materiovigilance for dissemination, where appropriate to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

GK sterile screws and S2
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    STRYKER

Manufacturer

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