Events

Rappel de Dynesys

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
    63103
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0237-2013
  • Date de mise en oeuvre de l'événement
    2012-09-04
  • Date de publication de l'événement
    2012-11-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113364
  • 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
    Posterior metal/polymer spinal system, fusion - Product Code NQP
  • Cause
    Zimmer inc., is initiating a correction to the patient labels of products manufactured before march 20i0 by the zimmer gmbh production site in winterthur, switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. while the information printed on the product label is correct, the info.
  • Action
    Zimmer, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated September 4, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Certificate of Acknowledgement Form was attached for customers to complete and return via fax to Zimmer, Inc. at 574 372-4265.

Device

Dynesys
  • Modèle / numéro de série
    REF Number: 01.03710.645, Lot 2323776, 2340853, 2347195, 2347196, 2349405, 2352968, 2361598, 2363757, 2368549, 2371803, 2374584, 2374695, 2390243, 2390244, 2392322, 2394946, 2395677, 2410170, 2410171, 2413068, 2414198, 2417869, 2419315, 2419317, 2424170, 2430156, 2439598, 2449297, 2452033, 2454477, 2455648, 2455649, 2469131, 2469132,
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    Dynesys¿ Universal spacer 6-45
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Adresse du fabricant
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 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