Events

Rappel de WAXING COPING CONTOUR

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par ZIMMER DENTAL 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
    47359
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2017-07-31
  • 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 dental is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard instructions for use (ifus). all listed products were missing supplemental ifus. affected customers are being provided with instructions on how to obtain the supplemental ifus from the website ifu.Zimmerdental.Com or by contacting zimmer's e-labeling services section.

Device

WAXING COPING CONTOUR
  • Modèle / numéro de série
    Model Catalog: ZOCWAX4S (Lot serial: 62602470); Model Catalog: ZOCWAX3S (Lot serial: 62602470); Model Catalog: ZOCWAX4S (Lot serial: 63432495); Model Catalog: ZOCWAX3S (Lot serial: 63432495); Model Catalog: ZOCWAX4S (Lot serial: 63155008); Model Catalog: ZOCWAX3S (Lot serial: 63155008); Model Catalog: ZOCWAX4S (Lot serial: 63240239); Model Catalog: ZOCWAX3S (Lot serial: 63240239); Model Catalog: HLA4G (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: ZOCWAX3S (Lot serial: 63331292); Model Catalog: 2224 (Lot serial: 63241114); Model Catalog: 2223 (Lot serial: 63241114); Model Catalog: 2224 (Lot serial: 63426543); Model Catalog: 2223 (Lot serial: 63426543); Model Catalog: 2224 (Lot serial: 63321266); Model Catalog: 2223 (Lot serial: 63321266); Model Catalog: 2224 (Lot serial: 63503028); Model Catalog: 2223 (Lot serial: 63503028); Model Catalog: 2224 (Lot serial: 63426542); Model Catalog: 2223 (Lot serial: 63426542); Model Catalog: ZOAT34 (Lot serial: 63145351); Model Catalog: HLA5G (Lot serial: >100 NUMBE
  • Description du dispositif
    WAXING COPING CONTOUR;TAPERED SCREW-VENT GOLD ABUTMENTS;THREAD RETRIEVER DRILL AND GUIDE SLEEVES;ABUTMENT TRY-IN CONTOUR;ZIMMER DENTAL ONE-PIECE IMPLANT
  • Manufacturer
    ZIMMER DENTAL INC.

Manufacturer

ZIMMER DENTAL INC.
  • Adresse du fabricant
    CARLSBAD
  • 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