Events

Retiro De Equipo (Recall) de REFLECTION 3 ACETABULAR SYSTEM - 0 DEG XLPE ACETABULAR LINER

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
    44912
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-06-24
  • 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
    Smith & nephew inc. has initiated a voluntary field safety corrective action/recall of the ceramic hip prostheses. the current hip prostheses ifus do not provide adequate instruction on the revision surgeries due to ceramic failure. the ifu does not provide the detailed instructions that if a hip prostheses revision is required due to a fractured ceramic component revisions shall only be performed using a ceramic femoral ball head in order to prevent any potential undue wear of the revision components.

Device

REFLECTION 3 ACETABULAR SYSTEM - 0 DEG XLPE ACETABULAR LINER
  • Modelo / Serial
    Model Catalog: 71339562 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71339560 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71339558 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71339556 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71339554 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71339552 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71339550 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71339548 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71338684 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71338683 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71338682 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71338681 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71338680 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71338679 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71337558 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71337556 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog:
  • Descripción del producto
    REFLECTION 3 ACETABULAR SYSTEM - 0 DEG XLPE ACETABULAR LINER;ECHELON HIP SYSTEM -POROUS STRAIGHT STEM FEMORAL COMPONENT W/CALCAR COLLAR;REFLECTION 3 ACETABULAR SYSTEM - 20 DEG XLPE ACETABULAR LINER;ECHELON HIP SYSTEM - POROUS STRAIGHT STEM FEMORAL COMPONE
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

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