Events

Recall of Lower extremity external prosthesis Total Knee 2100

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
    2011-03-03
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/prothese-externe-de-membre-inferieur-total-knee-2100-ossur-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
    The Afssaps was informed on 15/02/2011 of the implementation of a recall made by the company OSSUR. The concerned prosthetists have received the attached mail (03/03/2011) (74 KB).

Device

Lower extremity external prosthesis Total Knee 2100
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Ossur

Manufacturer

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