Retiro De Equipo (Recall) de Device Recall METS

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Stanmore Implants Worldwide Ltd..

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
  • Causa
    The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
  • Acción
    Stanmore Implants sent an Urgent Field Safety Notice dated November 25, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to immediately check their internal inventory and quarantine all subject devices, circulate the Field Safety Notice internally to all interested/affected parties, maintain awareness of the notice internally until all required actions have been completed within their facility, inform Stanmore Implants if any of the subject devices have been distributed to other organizations, complete the attached customer response form and list of affected batches form, return the completed form and any affected devices to their S/W Representative. Customers with questions were instructed to contact their local sales representative.


  • Modelo / Serial
    A10337, A11525, A7823, A9990, A11289, A11979, A12134, A7186, A8679, A9743, A10344, A10629, A10791, A10348a, A11198, A11557, A11895, A12090, A12129, A12220, A12223, A12229
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA
  • Descripción del producto
    Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short || The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
  • Manufacturer


  • Dirección del fabricante
    Stanmore Implants Worldwide Ltd., 210 Centennial Avenue Centennial Park, Centennial Park, Borehamwood United Kingdom
  • Empresa matriz del fabricante (2017)
  • Source