Events

Retiro De Equipo (Recall) de Norian CRS Rotary Mixer Cement 10cc sterile

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 Synthes USA (HQ), 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
    53496
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0269-2010
  • Fecha de inicio del evento
    2009-09-14
  • Fecha de publicación del evento
    2009-11-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85637
  • 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
    Methyl Methacrylate For Cranioplasty - Product Code GXP
  • Causa
    Non-conforming material - increased set time. potential clinical ramifications associated with increased set time and decreased strength include extrusion of unset material and fragmentation of cured material. the risk of norian fragmentation post cure increases with a larger defect and a thicker layer of product. customers were advised to call synthes at 1-800-479-6329 to obtain a return autho.
  • Acción
    The firm issued an Urgent Medical Device Recall letter dated 9/17/09 via USPS certified mail. The letter informed customers of the problem and the need to return the product. Sales Consultants that were shipped the device were notified by teleconference on 9/14/09. Consultants were instructed to go to their accounts to remove the product from inventory. Customers were advised to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Questions are directed to Synthes at 800-620-7025 x 5453 or 610-719-5453 or to your Synthes CMF Sales Consultant.

Device

Norian CRS Rotary Mixer Cement 10cc sterile
  • Modelo / Serial
    Catalog number 614.10.01S. Lot number N996352
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    The product was shipped to medical facilities in CO, KS, MA, MO, NY, SC, TX, UT, and WA.
  • Descripción del producto
    Norian CRS Rotary Mixer Cement 10cc sterile
  • Manufacturer
    Synthes USA (HQ), Inc.

Manufacturer

Synthes USA (HQ), Inc.
  • Dirección del fabricante
    Synthes USA (HQ), Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA