Events

Retiro De Equipo (Recall) de COCR MODULAR NECK COMPONENTS - MODULAR NECK ANTEVERTED

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SMITH & NEPHEW 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
    42941
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-11-23
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    During a recent review of product complaints and clinical study data associated with the modular hip prostheses a higher rate of complaints was observed in comparison with the comparable monolithic hip prostheses.

Device

COCR MODULAR NECK COMPONENTS - MODULAR NECK ANTEVERTED
  • Modelo / Serial
    Model Catalog: 71352117 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71352116 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71352509 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71352508 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71352507 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71352501 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71352505 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71352504 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71352503 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71352502 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71352506 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71352406 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71352405 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71352401 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71352403 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71352402 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog:
  • Descripción del producto
    COCR MODULAR NECK COMPONENTS - MODULAR NECK ANTEVERTED;SMF HIP STEM SYSTEM - STEM WITH STIKTITE;SMF HIP STEM SYSTEM - STEM RSA;REDAPT REVISION FEMORAL SYSTEM MODULAR SLEEVED REVISION;COCR MODULAR NECK COMPONENTS - MODULAR NECK HIGH OFFSET;REDAPT REVISION
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

SMITH & NEPHEW INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Smith & Nephew plc
  • Source
    HC