Events

Rappel de NEXGEN COMP KNEE SOL LEG KNEE-POST STAB LPS-FLEX FEM COMP OPTION ZIMALOY

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par ZIMMER BIOMET CANADA INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    83897
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2017-12-04
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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
  • Description du dispositif
    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.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “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