Events

Rappel de Device Recall Zimmer Dental Tapered ScrewVent T Implant

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States 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
    68584
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2050-2014
  • Date de mise en oeuvre de l'événement
    2014-06-25
  • Date de publication de l'événement
    2014-07-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-10-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128266
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Implant, endosseous, root-form - Product Code DZE
  • Cause
    Zimmer dental is conducting a voluntary recall of a single lot of the tapered screw-vent implant, catalog number tsvt6b13, lot number 62284006, due to a potential crack in the cap of the outer vial.
  • Action
    Recall notification letters sent to customers on 06/25/14. The recall letter, titled "URGENT DEVICE RECALL NOTICE", delivered to customers via a courier, with instructions for returning any unused affected product. The recall letter was accompanied with a response form and provided the following information to customers: product information with codes, reason for recall, risks, responsibilities, MedWatch Reporting and contacting information.

Device

Device Recall Zimmer Dental Tapered ScrewVent T Implant
  • Modèle / numéro de série
    Catalog Number TSVT6B13, Lot Number 62284006. 5-year expiration. January 2018.
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Adresse du fabricant
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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
    USFDA