Events

Retiro De Equipo (Recall) de Device Recall Ovation Hip Stem, REF 2010002, Hip Stem Inserter, NonSterile, Ortho Development, Draper

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 Ortho Development 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
    57747
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1670-2011
  • Fecha de inicio del evento
    2011-01-11
  • Fecha de publicación del evento
    2011-03-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-11-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97306
  • 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, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • Causa
    Component of total hip arthroplasty may break during surgical procedure.
  • Acción
    Ortho Development Corporation notified Field representatives of the issue and conditions that could lead to failure by e-mail on December 14, 2010. Redesigned product is being produced for replacement. For questions regarding this recall call 801-619-3450.

Device

Device Recall Ovation Hip Stem, REF 2010002, Hip Stem Inserter, NonSterile, Ortho Development, D...
  • Modelo / Serial
    All lots
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including AZ, CA, CO, FL, MI, NV, OR, and UT.
  • Descripción del producto
    Ovation Hip Stem, REF 201-0002, Hip Stem Inserter, Non-Sterile, Ortho Development, Draper, Utah 84020. || The Ovation Hip System is intended for use in total hip arthroplasty. The hip stem inserter is an instrument used to seat the hip stem in the femur. There is a notch in the top of the hip stem, and the hip stem inserter has a corresponding tip at the end of the instrument. The tip of the inserter is designed to fit into the notch of the hip stem, as a guide. Once this is inserted, the surgeon will tap on the opposite end of the inserter with a hammer to seat the press-fitted stem assembly.
  • Manufacturer
    Ortho Development Corporation

Manufacturer

Ortho Development Corporation
  • Dirección del fabricante
    Ortho Development Corporation, 12187 South Business Park Dr, Draper UT 84020
  • Empresa matriz del fabricante (2017)
    Ortho Development Corporation
  • Source
    USFDA