Events

Retiro De Equipo (Recall) de Symmetric Total Knee 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 Signal Medical 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
    69420
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0111-2015
  • Fecha de publicación del evento
    2014-10-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-03-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130498
  • 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
    Packaging of a device was compromised.
  • Acción
    Signal Medical sent a Notice letter dated September 30, 2014 to customers. Customers were instructed to carefully inspect devices to ensure package integrity before using. If packaging is compromised it should not be used. Return the affected device and packaging to Signal Medical Corporation. Replacement devices with new packaging configuration is shipped to each location with the old packaging configuration in the event that the packaging is found to be compromised. For questions contact Signal Medical Corp. at 1-800-246-6324.

Device

Symmetric Total Knee Femoral Component
  • Modelo / Serial
    Catalog # 22-01-02106; Lot # 1110; Serial # L0259; Size 6R  Catalog #22-01-02106; Lot # 2910; Serial # L0533; Size 6R  Catalog # 22-01-02003, Serial #s L0280,L0283, L0284, L0285, L0287, L0288, L0615, Size 3 L  Catalog # 22-01-02004, Serial # l0358, Size 4L  Catalog # 22-01-02005, Serial # L0809; Size 5L  Catalog #22-01-02006; Serial #s L0692, L0842, L0485, L0483, L0486, L0841, L0844, L0847, Size 6L  Catalog # 22-01-02007, Serial #s L0721, L0786, L0787, L0770, L0772, L0775, Size 7L  Catalog #22-01-02103, Serial #s L0265, L0272, Size 3R  Catalog # 22-01-02104, Serial #s L0479, L0515, L0517, Size 4R  Catalog # 22/01-02106, Serial # L0338, L0508, L0537, L0853, L0867, L0872, L0873, Size 6R  Catalog #22-01-02107, Serial #s L0749, L0758, L0760, L0755, L0759, L0762, Size 7R
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US (Nationwide) in the state of: MO and internationally to: Panama.
  • Descripción del producto
    Symmetric Total Knee Femoral Components || Product Usage: || Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).
  • Manufacturer
    Signal Medical Corporation

Manufacturer

Signal Medical Corporation
  • Dirección del fabricante
    Signal Medical Corporation, 400 Pyramid Dr, Marysville MI 48040-2463
  • Empresa matriz del fabricante (2017)
    Signal Medical Corporation
  • Source
    USFDA