Events

Recall of Total Femoral Prosthesis Knee Component - Asymmetric Hi-Flex, Optetrak System (Orthopedics)

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 Exactech.

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
  • Event ID
    201413889
  • Date
    2014-10-17
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/composant-femoral-de-prothese-totale-de-genou-hi-flex-asymetrique-systeme-optetrak-orthopedie-exactech-rappel
  • 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
    ANSM has been informed of the implementation of a recall made by Exactech. The users concerned received the attached mail (17/10/2014) (143 KB). This safety action is registered with the ANSM under the number 201413889 .. You will have the possibility of consulting its progress report on the Directory of the reports of materialovigilanc. by entering this registration number.

Device

Total Femoral Prosthesis Knee Component - Asymmetric Hi-Flex, Optetrak System (Orthopedics)
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Exactech

Manufacturer

Exactech