Events

Retiro De Equipo (Recall) de Device Recall DePuy P.F.C. Sigma Knee System, NonPorous Cruciate Retaining Femoral Component

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 Orthopaedics, 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
    52088
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1686-2009
  • Fecha de inicio del evento
    2009-05-07
  • Fecha de publicación del evento
    2009-08-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82075
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Causa
    There may be a crack on the lateral side of the condyle in the posterior chamfer region. the device is used as a orthopedic knee implant.
  • Acción
    The firm's sales staff was notified by email on May 7, 2009, and the recall was expanded to include additional lots on May 29, 2009, instructing them to remove the affected lots from their inventory and the inventory of any consignees, to provide the consignees with a copy of the recall letter, and to return the product to the firm. Hospital consignees were notified by letter dated May 7, 2009, as well as by updated letter on May 29, 2009. A dear doctor letter dated May 29, 2009 was issued to implanting surgeons advising them of the issue. Direct questions to Depuy Customer Service by calling 1-800-366-8143.

Device

Device Recall DePuy P.F.C. Sigma Knee System, NonPorous Cruciate Retaining Femoral Component
  • Modelo / Serial
    Lot Numbers: 2833275, 2833276, 2833277, 2833278, 2833279, 2835157, 2835908, 2835909, 2837020, 2838165, 2839666, 2839667, 2839668, 2839670, 2839671, 2839672, 2839675, 2840479, 2840480, 2841253, 2842526, 2842527, 2842528, 2842930, 2843263, 2843265, 2843267, 2843268, 2843270, 2844381, 2844383, 2844386, 2844796, 2844799, 2844800, 2845530, 2845534, 2846326, 2846330, 2846332, 2852392, 2852394, 2855015, 2855016, 2857271, 2857272, 2857881, 2857882, 2857884, 2857885, 2858572, 2858573, 2858574, 2858576, 2858577, 2859195, 2859197, 2859198, 2859199, 2859915, 2859916, 2859917, 2859920, 2860448, 2860449, 2860452, 2860455, 2860456, 2861519, 2861520, 2861699, 2862589, 2862591, 2863841, 2863843, 2864833, 2864834, 2864835, 2864837, 2864839, 2866038, 2868313, 2868314, 2869119, 2869120, 2869121, 2869122, 2869123, 2871182, 2871183, 2871835, 2871836, 2874434, 2874435, 2874436, 2876307, 2876309, 2876311, 2876314, 2881638, 2885685, 2885689, 2886278, 2886968 and 2886974.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide.
  • Descripción del producto
    DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retaining Femoral Component, 73 mm M/L 69 mm A/P, 5 left, sterile, DePuy Orthopaedics, Inc., Warsaw, IN; REF 96-0005. || The device is used for total or unicompartmental knee arthroplasty and is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
  • Manufacturer
    Depuy Orthopaedics, Inc.

Manufacturer

Depuy Orthopaedics, Inc.
  • Dirección del fabricante
    Depuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Source
    USFDA