Retiro De Equipo (Recall) de Device Recall Straumann Emdogain

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 Straumann Manufacturing, Inc..

¿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
  • Estado del evento
    Open, Classified
  • País 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
    Biologic material, dental - Product Code NQA
  • Causa
    A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
  • Acción
    Customer notification letters were distributed 3/23/18. Action to be taken: 1. Check your inventory for the above listed article and lot numbers and return all unused/unpackaged Emdogain using the enclosed prepaid UPS label as indicated on the Customer Confirmation Form. Your account will be credited upon receipt. 2. If you have already unpacked the Emdogain from the outer box, the lot number on the blister package will be different. Please check your Emdogain for the syringe blister lot numbers listed above and return them for credit using the enclosed prepaid UPS label as indicated on the Customer Confirmation Form. 3. If you have already used the Emdogain with the above listed article and lot numbers, please document receipt of this Field Safety Notice in the applicable patient files. Complete and return the enclosed Customer Confirmation Form via fax to the number listed on the form. Please also report the outcome of the surgical treatment with this product on the enclosed Customer Treatment Outcome Form and fax the form to the number listed on the form. 4. For all cases complete and return the enclosed Customer Confirmation Form and return to Straumann using the enclosed UPS label (if returning product) or via fax (if notifying us the product has already been used). This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. Updated Notification letters including an additional lot number were distributed beginning 4/18/18.


  • Modelo / Serial
    Lot NZ535, Syringe Blaster Lot LP632A, Exp 6/30/2018 Lot PG631, Syringe Blaster Lot MX842B, Exp 2/28/2019 Lot NP739, Syringe Blaster Lot NE101B, Exp 3/31/2019 Lot PY818, Syringe Blaster Lot PT888A, Exp 1/31/2020
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Distributed US Nationwide and Puerto Rico.
  • Descripción del producto
    Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W
  • Manufacturer


  • Dirección del fabricante
    Straumann Manufacturing, Inc., 60 Minuteman Rd, Andover MA 01810-1008
  • Empresa matriz del fabricante (2017)
  • Source