Events

Rappel de VERSA-FX II Femoral Fixation System Expiration Date: Prior to June 2023

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Zimmer Pty Ltd.

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
    RC-2013-RN-00950-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-09-16
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00950-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Zimmer recently conducted a review of historic packaging validations completed. based on this review, it was determined that a subset of product packaged at a single zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. this testing determined that a single packaging tray configuration used for versa-fx ii femoral fixation system, which consists of an inner and outer sterile tray, failed the leak test due to damage in the corner of the inner cavity.
  • Action
    Zimmer is requesting hospitals to inspect the packages as described in the device package insert. If a inner package is determined to have been compromised, the device is to be quarantined and a Zimmer sales representative contacted.

Device

VERSA-FX II Femoral Fixation System Expiration Date: Prior to June 2023
  • Modèle / numéro de série
    VERSA-FX II Femoral Fixation SystemExpiration Date: Prior to June 2023Multiple Item Numbers affected (see attached)ARTG Number : 112735
  • Manufacturer
    Zimmer Pty Ltd

Manufacturer

Zimmer Pty Ltd
  • 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
    DHTGA