Events

Rappel de MAGNA-FX CANNULATED SCREW FIXATION SYSTEM AND INSTRUMENTATION

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
    32878
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-05-06
  • 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
    These screws are packaged with a double barrier system two plastic trays and two tyvek lids to provide sterile integrity. process monitoring conducted as part of the standard packaging process identified that in some instances a small hole may be present in the inner tray. the holes were found to be caused by a single tool used by the tray supplier in the manufacturing process and estimated to be present in less than 10% of the affected devices. the outer tray is not affected and the device's sterile integrity remains until the outer tray is opened. no product complaints have been reported for this issue.

Device

MAGNA-FX CANNULATED SCREW FIXATION SYSTEM AND INSTRUMENTATION
  • Modèle / numéro de série
    Model Catalog: 00114205130 (Lot serial: 63296605); Model Catalog: 00114606532 (Lot serial: 63290146); Model Catalog: 00114606099 (Lot serial: 63290146); Model Catalog: 00114205138 (Lot serial: 63290146); Model Catalog: 00114205124 (Lot serial: 63290146); Model Catalog: 00114205130 (Lot serial: 63290146); Model Catalog: 00114606532 (Lot serial: 63290143); Model Catalog: 00114606099 (Lot serial: 63290143); Model Catalog: 00114205138 (Lot serial: 63290143); Model Catalog: 00114205124 (Lot serial: 63290143); Model Catalog: 00114205130 (Lot serial: 63290143); Model Catalog: 00114606532 (Lot serial: 63303825); Model Catalog: 00114606099 (Lot serial: 63303825); Model Catalog: 00114205138 (Lot serial: 63303825); Model Catalog: 00114205124 (Lot serial: 63303825); Model Catalog: 00114205130 (Lot serial: 63303825); Model Catalog: 00114606532 (Lot serial: 63308562); Model Catalog: 00114606099 (Lot serial: 63308562); Model Catalog: 00114205138 (Lot serial: 63308562); Model Catalog: 00114205124 (Lot serial: 63296605); Mod
  • Description du dispositif
    MAGNA-FX CANNULATED SCREW FIXATION SYSTEM AND INSTRUMENTATION;COMPRESSION SCREW;TRILOGY ACETABULAR SYSTEM-BONE SCREWS
  • 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