Events

Rappel de NEXGEN SIZE 2 TIBIA WITHOUT POLY PLUGS-CUSTOM MADE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par ZIMMER 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
    33850
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-01-20
  • 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 initiating a lot specific recall of the above-listed nexgen option tibial plates that were custom produced. field complaints were received indicating the articular surface was loose in the tibial plate. investigation of the tibial plate returned with the complaint confirmed the dovetail feature was undersized. our records indicated that five units were produced of which three were used in surgery.

Device

NEXGEN SIZE 2 TIBIA WITHOUT POLY PLUGS-CUSTOM MADE
  • Modèle / numéro de série
    Model Catalog: 32-8554-505-85 (Lot serial: 95006446); Model Catalog: 32-8554-505-73 (Lot serial: 95006443); Model Catalog: 32-8554-505-73 (Lot serial: 95006446); Model Catalog: 32-8554-505-87 (Lot serial: 95006445); Model Catalog: 32-8554-505-86 (Lot serial: 95006445); Model Catalog: 32-8554-505-85 (Lot serial: 95006445); Model Catalog: 32-8554-505-84 (Lot serial: 95006445); Model Catalog: 32-8554-505-73 (Lot serial: 95006445); Model Catalog: 32-8554-505-87 (Lot serial: 95006444); Model Catalog: 32-8554-505-86 (Lot serial: 95006444); Model Catalog: 32-8554-505-85 (Lot serial: 95006444); Model Catalog: 32-8554-505-84 (Lot serial: 95006444); Model Catalog: 32-8554-505-73 (Lot serial: 95006444); Model Catalog: 32-8554-505-87 (Lot serial: 95006443); Model Catalog: 32-8554-505-86 (Lot serial: 95006443); Model Catalog: 32-8554-505-85 (Lot serial: 95006443); Model Catalog: 32-8554-505-84 (Lot serial: 95006443); Model Catalog: 32-8554-505-86 (Lot serial: 95006446); Model Catalog: 32-8554-505-87 (Lot serial: 95006446
  • Description du dispositif
    *
  • Manufacturer
    ZIMMER INC.

Manufacturer

ZIMMER INC.
  • Adresse du fabricant
    WARSAW
  • 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