Events

Recall of Total Knee Knee models TK1100, TK1900, TK2000 and TK2100

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
    2006-04-21
  • 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-series-de-genou-total-knee-modeles-tk1100-tk1900-tk2000-et-tk2100-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    The OSSUR company has withdrawn from the market on March 25, 2006 the numbers of series mentioned in the attached table (21/04/2006) (13 KB) of the medical device called Total Knee Knee models TK1100, TK1900, TK2000 and TK2100 following the presence Defective fastenings on certain Total Knee knee elements. OSSUR informs that the Total Knee knee device must be replaced even if it does not cause any discomfort to the patient in order to avoid a risk. injury or destruction of other elements of the prosthesis .. This information is for orthopedists (functional rehabilitation centers) and local correspondents of materiovigilance for dissemination, where appropriate to the services concerned .. The company has directly notified the recipients of the incriminated series using the enclosed messages (information to the recipients of the mentioned lots (21/04/2006) (12 KB) & information gén erale Ossur (21/04/2006) (13 Kb)). The competent authorities of the countries concerned are informed of this measure by the manufacturer.

Device

Total Knee Knee models TK1100, TK1900, TK2000 and TK2100
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    OSSUR

Manufacturer

OSSUR
  • Source
    LAANSM