Events

Retiro De Equipo (Recall) de Device Recall Lineage Shell

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 MicroPort Orthopedics 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
    75063
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0686-2017
  • Fecha de inicio del evento
    2016-06-21
  • Fecha de publicación del evento
    2016-12-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149413
  • 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
    Revision rate trends from within the microport orthopedics inc. database evaluated for the modular head metal on metal tha systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head conserve(r) systems and dynasty(r) metal acetabular liner systems.
  • Acción
    MicroPort sent an Urgent Field Safety Notice dated June 22, 2016, to all affected customers notifying them of the change in the instructions for use on July 7th, 2016 by email. The firm also notified US hospitals where the implantation surgeries occurred within the last twelve (12) months by letter on July 13th, 2016 delivered by FedEx Priority. Customers were asked to complete and return the enclosed form even if they do not have any affected product to return by fax to 1-901-451-6032 or PostMarket@ortho.microport.com. For questions regarding this recall call 901-867-4771.

Device

Device Recall Lineage Shell
  • Modelo / Serial
    REF 36693646 Serial Numbers: 09230967, 09229086, 10230508  REF 36693848 Serial Numbers: 08228745, 10230509, 11235075  REF 36694050 Serial Numbers: 09229091, 09230501  REF 36694252 Serial Numbers: 09229131, 10230510  REF 36694454 Serial Numbers: LLALMB161A, 09230503  REF 36694656 Serial Numbers: 09230505, 11230847  REF 36694858 Serial Numbers: 09229167, 10230511  REF 36695060 Serial Numbers: 09229169, 09230506  REF 36695262 Serial Numbers: 09230507, 09229170  REF 36695464 Serial Numbers: 08228747, 10230512
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kingdom, and Vietnam.
  • Descripción del producto
    Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262, REF 36695464 || For use with the conserve metal head
  • Manufacturer
    MicroPort Orthopedics Inc.

Manufacturer

MicroPort Orthopedics Inc.