Events

Retiro De Equipo (Recall) de Device Recall ZMR Trabecular Metal

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 Zimmer 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
    60419
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0368-2012
  • Fecha de inicio del evento
    2011-11-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105389
  • 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
    Hip Prosthesis - Product Code LPH
  • Causa
    Lack of assurance of proper metal fatigue strength due to metal grain structure anomaly. in 2006 a recall was initiated as a result of the grain anomaly; however, these 4 lots had been split off during normal production and had not been included in the 2006 recall.
  • Acción
    On 11/16/11, Zimmer sent letters titled "URGENT MEDICAL DEVICE RECALL" to distributors via electronic mail and to risk managers and surgeons via FedEx indicating that the product must be immediately removed from use and quarantined. " Stop using the affected lots and place affected product in quarantine. " Review available product on the shelf " Identify those part/lot combinations listed in the recall communication " Immediately remove any implants found that match part/lot combinations listed in the recall communication and quarantine " Return affected lots and signature of acknowledgement to Zimmer

Device

Device Recall ZMR Trabecular Metal
  • Modelo / Serial
    Item number: 00-9996-019-35 Lot number: 00104621
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA (NY), AUSTRALIA, SWITZERLAND, and DENMARK
  • Descripción del producto
    Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Hip Prosthesis Femoral Stems: || FEMORAL BODY REVISION NITRIDED POROUS 12/14 NECK TAPER STANDARD 40 MM NECK OFFSET CONE BODY SIZE C 35 MM BUILD-UP TIVANIUM TI-6AL-4V ALLOY STERILE. Item number: 00-9996-019-35
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Dirección del fabricante
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA