Events

Retiro De Equipo (Recall) de Device Recall Spectrum Designs Medical Anatomical Chin Implant

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 Spectrum Designs 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
    44735
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1265-2007
  • Fecha de inicio del evento
    2007-07-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-07-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64332
  • 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
    Anatomical Chin Implant - Product Code LZK
  • Causa
    Mispackaging/mislabeing: a portion of the lot may be labeled as containing nasal implants.
  • Acción
    The firm initiated the recall on 07/24/2007 by contacting the customer (distributor) who filed the original complaint of mislabeling by email. The firm followed-up by sending recall letters (dated July 24, 2007) via FedEx or certified mail with signature confirmation to the one other direct account who received the recalled product on 08/03/2007. Customers were instructed to check their inventory for mislabeled products and call Spectrum at (800)239-6399 to report the number of this product being returned. They were given an address for product return. The firm indicated they will examine returned products, and scrap after examination.

Device

Device Recall Spectrum Designs Medical Anatomical Chin Implant
  • Modelo / Serial
    Catalog Number 250-134S; Lot # 31140; Serial Numbers BAHO45 through BAH144
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide: California and China
  • Descripción del producto
    Spectrum Designs Medical Anatomical Chin Implant; Catalog Number 250-134S; Lot # 31140; Serial Numbers BAHO45 through BAH144
  • Manufacturer
    Spectrum Designs Inc

Manufacturer

Spectrum Designs Inc
  • Dirección del fabricante
    Spectrum Designs Inc, 6387 Rose Ln Ste B, Carpinteria CA 93013-2937
  • Source
    USFDA