Events

Retiro De Equipo (Recall) de NEXGEN COMP KNEE SOL LEG KNEE-POST STAB LPS-FLEX FEM COMP OPTION ZIMALOY

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ZIMMER BIOMET CANADA 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
    83897
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-12-04
  • 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
    Zimmer biomet is conducting a medical device recall for various highly polished hip and knee implants that were packaged in a low density polyethylene (ldpe) bag. the ldpe bag may become adhered to the highly polished surface leaving residue or material from the ldpe bag on the implant after it is removed from the bag. this recall is to remove additional lots not previously included in a similar recall initiated in january 2016.

Device

NEXGEN COMP KNEE SOL LEG KNEE-POST STAB LPS-FLEX FEM COMP OPTION ZIMALOY
  • Modelo / Serial
    Model Catalog: 00-5964-017-52 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 00-5964-017-51 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 00-5964-016-52 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 00-5964-016-51 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 00-5964-015-52 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 00-5964-015-51 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 00-5964-014-52 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 00-5964-014-51 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 00-5964-013-52 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 00-5964-013-51 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 00-7843-014-26 (Lot serial: 61741806); Model Catalog: 00811400210 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 00811400200 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 00811400000 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 00784301336 (Lot serial: 62120673); Model Catalog: 00784
  • Descripción del producto
    NEXGEN CKS LPS-FLEX OPTION FEMORAL COMPONENT;VERSYS HIP SYSTEM-FEMORAL STEM BEADED FULLCOAT PLUS;CPT HIP SYSTEM-FEMORAL STEM NECK TAPER WITH CENTRALIZER;VERSYS HIP SYSTEM-REVISION FEMORAL STEM BEADED FULLCOAT;NEXGEN CKS CR-FLEX POROUS FEMORAL COMPONENT;VE
  • Manufacturer
    ZIMMER BIOMET CANADA INC.

Manufacturer

ZIMMER BIOMET CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    HC