Events

Recall of Icelock 551 expulsion valves

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 Ossur.

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
    2009-07-09
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-des-valves-d-expulsion-icelock-551-fabriquees-par-la-societe-ossur
  • 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 Afssaps was informed on 25/06/2009 of a recall of two lots of Icelock 551 expulsion valves made by the company Ossur on 01/07/2009 following the lack of manufacture of these valves. The users concerned, in France, received the attached mail (09/07/2009) (115 KB). The competent European authorities have been informed of this measure by the manufacturer. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for diffusion to the concerned services.

Device

Icelock 551 expulsion valves
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Ossur

Manufacturer

Ossur
  • Manufacturer Parent Company (2017)
    Össur hf
  • Source
    LAANSM