Events

Retiro De Equipo (Recall) de Device Recall DURAGEN II DURAL REGENERATION MATRIX

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 Integra LifeSciences Corp.

¿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
    54253
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1081-2010
  • Fecha de inicio del evento
    2010-01-13
  • Fecha de publicación del evento
    2010-03-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87963
  • 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
    Dura substitute - Product Code GXQ
  • Causa
    One lot of suturable duragen dural regeneration matrix (# 1091575) did not pass stability testing at certain time points for suture retention strength and shrink temperature specifications.
  • Acción
    An "URGENT PRODUCT RECALL NOTIFICATION" dated January 13, 2010, was sent via Federal Express to customers. The notification described the product, problem, hazard involved and action to be taken by customers. In the event that the customers have in their possession any products from the specific lot number 1091576, the customers are being ask to please immediately quarantine all stock on hand and contact their local Integra Sales representative for further assistance and for arrangements of product return. The customers are being ask to return the enclosed "Recall Acknowledge and Return Form" indicating whether or not they possess any of the affected product identified. Integra will replace any product affected by this Recall that is returned. Please feel free to contact me at 609-936-5407 should you have any additional questions.

Device

Device Recall DURAGEN II DURAL REGENERATION MATRIX
  • Modelo / Serial
    Catalog Number DURS3391; Lot number 1091575
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide distribution:Ca, NY, TX, CO, VA, SC, IA, MO, IL, LA, OR, OH, WI, FL, DC, DE, MD, MN.
  • Descripción del producto
    Suturable DuraGen Dural Regeneration Matrix; || Non-Pyrogenic; || Sterility guaranteed unless package is damaged or opened. Rx only. || Manufacturer: Integra LifeSciences Corporation, Plainsboro, NJ 08536 || Suturable DuraGen is an absorbable implant for repair of dural defects. It is indicated as a dural substitute for the repair of dura matter.
  • Manufacturer
    Integra LifeSciences Corp

Manufacturer

Integra LifeSciences Corp