Events

Rappel de 3i T3, Full Osseotite Tapered & Parallel Walled Dental Implants

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-2014-RN-01222-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-12-02
  • 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-2014-RN-01222-1
  • 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 has identified a visually observable condition which may be present on a limited number of the identified implants. the condition is caused by the implant coming into contact with residual machining fluid which was not adequately degreased from a portion of 1 lot of packaging cylinders. the residual machining fluid causes the implants to be discoloured. biomet 3i has determined that there are no known health effects of the residue. this has been confirmed through cytotoxicity and endotoxicity tests, which have yielded negative results for toxins on residue-affected samples.
  • Action
    No affected units are known to have been implanted in Australia. Customers are advised to return affected products to BIOMET 3i Australia Pty Ltd for replacement with unaffected units. This action has been closed-out on 14/07/2016.

Device

3i T3, Full Osseotite Tapered & Parallel Walled Dental Implants
  • Modèle / numéro de série
    3i T3, Full Osseotite Tapered & Parallel Walled Dental Implants3i T3 Non-Platform Switched Tapered Implant 3.25X8.5 -15.0mmCatalog Number BOST3211Lot Numbers: 2014051395 (Expiry: 12/11/2018), 2014051817 (Expiry: 12/09/2018)Full Osseotite Certain Implant 3.25X8.5 - 15.0mmCatalog Number XIFNT3211 Lot Number 2014051477 (Expiry: 12/06/2018)Parallel Walled Certain 2 Implant 3.25X8.5 - 18mmCatalog Number: XIFOSM311Lot Number: 2014051368 (Expiry: 12/03/2018)ARTG Number100482
  • 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