Events

Retiro De Equipo (Recall) de Device Recall SalineFilled SPECTRUM Breast Implants

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 Mentor Texas, LP..

¿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
  • ID del evento
    76868
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2070-2017
  • Fecha de inicio del evento
    2017-03-27
  • Fecha de publicación del evento
    2017-05-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154428
  • 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, breast, inflatable, internal, saline - Product Code FWM
  • Causa
    Missing dome pack accessory.
  • Acción
    Mentor sent an Recall Notification letter dated March 27, 2017 was sent to consignees (hospitals/doctors) . Actions Requested If you have already implanted a device from this lot, there is no risk to patient health and you do not need to take any action. Immediately identify all unused units and return them to Mentor per the normal return process.Forward this notice to anyone in your facility that needs to be informed. If you have sent these units to another facility, forward this notice to that facility. Maintain awareness of this notice until all units from lot number 7377332 in your inventory have been returned. We apologize for any inconvenience this may cause. Mentor stands confidently behind the safety and quality of the products we supply, and we appreciate your cooperation in this matter. Please know the U.S. Food and Drug Administration (FDA) has been notified of this voluntary field action. If you have any questions related to this notice, please contact your local Mentor Sales Representative or Mentor Customer Service at 1-800-235-5731. For further questions please call (972) 252-6060. Thank you for your attention and cooperation.

Device

Device Recall SalineFilled SPECTRUM Breast Implants
  • Modelo / Serial
    Lot Number: 7377332
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    US Distribution to the states of : MI, CA, CT, IL, IN, NY, NC, OH and OK.
  • Descripción del producto
    Mentor Smooth Round SPECTRUM Post- || Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
  • Manufacturer
    Mentor Texas, LP.

Manufacturer

Mentor Texas, LP.
  • Dirección del fabricante
    Mentor Texas, LP., 3025 Skyway Cir N, Irving TX 75038-3524
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA