Events

Rappel de Navigator Surgical Kit/Tray, Tapered Navigator Surgical Kit/Tray, Contra-Angle Torque Driver Kit, Prosthetic Instrumentation Kit, Prosthetic System Driver Tray (Instrument kits which contains reusable dental instruments/ trays used to hold dental instruments during lab sterilization)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Biomet 3i Australia 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-00895-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-08-27
  • 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-00895-1
  • 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
    Biomet 3i recently conducted revised sterilization validation testing on all commercial surgical kits / trays. during these validations, certain surgical kits/trays did not meet the sterility assurance level (sal) of 10^-6 in all locations using the previously validated steam gravity sterilization method at twenty (20) minutes (testing was conducted at a half cycle time of ten (10) minutes). these devices, however, were shown to achieve an sal of 10^-6 in all challenged locations using a forty (40) minute exposure (testing was conducted at a half cycle time of twenty (20) minutes).
  • Action
    Biomet 3i is providing users with revised sterilisation instructions for the steam gravity sterilisation method. There is no change to the pre-vacuum sterilization method.

Device

Navigator Surgical Kit/Tray, Tapered Navigator Surgical Kit/Tray, Contra-Angle Torque Driver Kit,...
  • Modèle / numéro de série
    Navigator Surgical Kit/Tray, Tapered Navigator Surgical Kit/Tray, Contra-Angle Torque Driver Kit, Prosthetic Instrumentation Kit, Prosthetic System Driver Tray (Instrument kits which contains reusable dental instruments/ trays used to hold dental instruments during lab sterilization) Product Code: SGKIT, SGTRAY, SGTIKIT, SGTTRAY, NPSDK0, NCATD0, CATD0, NCATD0C,PSDT1, PSKDOARTG Numbers: 170743, 100988
  • Manufacturer
    Biomet 3i Australia Pty Ltd

Manufacturer

Biomet 3i Australia 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