Events

Retiro De Equipo (Recall) de Total Knee Knee models TK1100, TK1900, TK2000 and TK2100

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por OSSUR.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • Fecha
    2006-04-21
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    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
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Acción
    The OSSUR company has withdrawn from the market on March 25, 2006 the numbers of series mentioned in the attached table (21/04/2006) (13 KB) of the medical device called Total Knee Knee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
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    OSSUR

Manufacturer

OSSUR
  • Source
    LAANSM