Events

Retiro De Equipo (Recall) de Device Recall ORTHOCORD One Violet and One Blue Braided Composite Suture with MO7 Taper Needles

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 DePuy Mitek, Inc., a Johnson & Johnson Co..

¿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
    64706
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1174-2013
  • Fecha de inicio del evento
    2013-03-22
  • Fecha de publicación del evento
    2013-04-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116834
  • 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
    Suture, surgical, absorbable, polydioxanone - Product Code NEW
  • Causa
    The ifu provided with the free strand orthocord sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. while this statement is true for violet orthocord sutures, it is an inaccurate statement for blue orthocord free strand sutures. based on in-vivo strength retention study, a blue orthocord sutures maintain approximately 80% of strength at six.
  • Acción
    On March 22, 2013, firm notified consignees of recall via letter. Consignees were informed of the following: The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six weeks after implantation. As Blue and Violet ORTHOCORD free strand sutures share the same IFU, IFU-108147 will be revised. Consignees were requested to confirm the receipt of the letter by March 29, 2013.

Device

Device Recall ORTHOCORD One Violet and One Blue Braided Composite Suture with MO7 Taper Needles
  • Modelo / Serial
    ALL from Jan 1 2010 - Corrected IFU implementation date
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalog Number: 223114. || For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
  • Manufacturer
    DePuy Mitek, Inc., a Johnson & Johnson Co.

Manufacturer

DePuy Mitek, Inc., a Johnson & Johnson Co.
  • Dirección del fabricante
    DePuy Mitek, Inc., a Johnson & Johnson Co., 325 Paramount Drive, Raynham MA 02767-5199
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA