Events

Rappel de Universal Clamp System and UniWallis System (used during spinal cord surgery)

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-2016-RN-00232-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-08
  • 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-2016-RN-00232-1
  • 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 is initiating a recall for product correction to provide updated cleaning, disinfection and sterilisation instruction for use of universal clamp system (ifu, reference: sn2027-n-90001 and uniwallis system (ifu, references: 038wnan0000t). since the market launch of each products (universal clamp system and uniwallis system), the instruments were distributed with instruction for use related to the method for cleaning, disinfection and for steam sterilisation at health care facilities. however, the method was not adequately validated. instruments cleaned, disinfected, and sterilised under the former ifu for the universal clamp and/or uniwallis systems may not be sterile which can result in infection.
  • Action
    Zimmer is providing users with revised Instructions for Use and advising users to discard the previous IFU.

Device

Universal Clamp System and UniWallis System (used during spinal cord surgery)
  • Modèle / numéro de série
    Universal Clamp System and UniWallis System (used during spinal cord surgery)All lot numbers affectedARTG Number:157602
  • 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