Events

Retiro De Equipo (Recall) de Device Recall Strattice Reconstructuve Tissue Matrix for Stoma Reinforcement

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 LifeCell Corporation.

¿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
    56261
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2623-2010
  • Fecha de inicio del evento
    2010-07-12
  • Fecha de publicación del evento
    2010-09-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93085
  • 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
    Mesh, surgical - Product Code FTM
  • Causa
    Mislabeled -one lot of product labeled as 8 cm x 8 cm were actually cut using a 6 cm x 6 cm template.
  • Acción
    LifeCell issued Recall Notice letters dated July 12, 2010 to customers, identifying the affected product, the labeling issue, and actions to be taken by the customer. Two versions of the recall notification were sent, one for implanted units and one for those not yet implanted. Both letters stated that the mislabeling has no impact of the safety or effectiveness of the medical device. Replacement units were offered for all affected units. Those with unused units were to contact LifeCell Customer Solutions for return and replacement of the unit at 1-866-423-2433. Those with implanted units may contact LifeCell Customer Solutions at 1-866-423-2433 with any additional questions or concerns.

Device

Device Recall Strattice Reconstructuve Tissue Matrix for Stoma Reinforcement
  • Modelo / Serial
    Lot S10624, Exp. 2011-04.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution: USA, including the states of AZ, DC, FL, GA, ID, IL, KY, LA, MO, NC, OH, OK, OR, TX, WA, and WI.
  • Descripción del producto
    Strattice Reconstructive Tissue Matrix for Stoma Reinforcement. || 8 cm x 8 cm || Packaged in an inner foil pouch inside outer foil pouch tertiary carton. || LifeCell Corporation, One Millennium Way, Branchburg, NJ 08876 || Strattice is intended for use as a foil tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is used for repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. It is intended for single patient one time use.
  • Manufacturer
    LifeCell Corporation

Manufacturer

LifeCell Corporation
  • Dirección del fabricante
    LifeCell Corporation, 1 Millennium Way, Somerville NJ 08876-3876
  • Empresa matriz del fabricante (2017)
    Allergan Public Limited Company
  • Source
    USFDA