Retiro De Equipo (Recall) de Device Recall UltraFill DBM

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 Surgical Tissue Network, 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
    Recall
  • ID del evento
    63226
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0653-2013
  • Fecha de inicio del evento
    2012-03-14
  • Fecha de publicación del evento
    2013-01-07
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2014-12-02
  • Fuente del evento
    USFDA
  • 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
    Filler, bone void, calcium compound - Product Code MQV
  • Causa
    Surgical tissue network inc., dba tissuenet inc. recalled their ultrafill dbm putty-porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316l stainless steel particulates.
  • Acción
    Surgical Tissue Network sent a Notification of Voluntary Tissue Recall dated March 22, 2012, to all affected customers. The firm issued an additional notification letter on August 30, 2012. The letter identified the product, the problem, and action to be taken by the customer. Consignees were asked to return all listed products that remain in inventory. If the product was further distributed, they were asked to forward the recall information to their customers. Customers were instructed to contact TissueNet's Customer Service Department at 800-465-8800 x283 to coordinate return/replacement of the affected product. Customers with questions were instructed to call 800-465-8800 x230. For questions regarding this recall call 407-380-2424.

Device

  • Modelo / Serial
    Product Code: RT53010 Tissue ID: 07-175-330 through 07-175-359; TN61032-11-0017 through TN61032-11-0041; TN62034-11-0001 through TN62034-11-0024; TN62053-11-0155 through TN62053-11-0209; TN67049-11-0291 through TN67049-11-0316; TN70037-11-0020 through TN70037-11-0037; TN74060-11-0021 through TN74060-11-0047; TN74060-11-0050 through TN74060-11-0056
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution including Turkey, Greece, & Mexico.
  • Descripción del producto
    UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 10cc Product Code: RT53010 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information || TissueNet's Porcine DBM product line is used as a bone void filler.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Surgical Tissue Network, Inc., 7022 TPC Dr Ste 400, Orlando FL 32822-5140
  • Source
    USFDA