Events

Rappel de VANGUARD TOTAL KNEE SYSTEM - DCM - PS PLUS TIBIAL BEARINGS

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
    120077
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2017-02-21
  • 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 lot specific medical device field action for various polyethylene implants. the affected products are being removed due to the potential presence of elevated endotoxin levels that exceed the specification limit. the issue was discovered during routine bacterial endotoxin testing (bet). there have been no complaints received related to this issue. endotoxins (pyrogens) are substances found in certain bacteria. the fda-adopted standard for endotoxin levels is 20 eu/device. there were three samples during an approximate 6 week period that were found to exceed this level. as a result the devices manufactured during this period are being removed.

Device

VANGUARD TOTAL KNEE SYSTEM - DCM - PS PLUS TIBIAL BEARINGS
  • Modèle / numéro de série
    Model Catalog: 183740 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: XL-105925 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: XL-105924 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: XL-105923 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: XL-105914 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: XL-105903 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: XL-105833 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 141514 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 189080 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 189062 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 189040 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 189020 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 11-165236 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 11-165232 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 11-165226 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model
  • Classification du dispositif
    Orthopedic Devices
  • Description du dispositif
    VANGUARD TOTAL KNEE SYSTEM - DCM - PS PLUS TIBIAL;ARCOMXL RINGLOC LINER;MAXIM KNEE SYSTEM-STEMMED TIBIAL TRAY COMPONENT;TOTAL KNEE SYSTEM - ANTERIOR STABILIZED BEARINGS;RINGLOC BIPOLAR ACETABULAR COMPONENT;MAXIM KNEE SYSTEM-PRIMARY TIBIAL TRAY;HYBRID GLEN
  • 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