Events

Rappel de Biomet 3i Dental Implants

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Implant Innovations 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
    17693
  • Date de mise en oeuvre de l'événement
    2014-11-21
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Biomet 3i Australia Pty Ltd (NZ), 16 Huapai Street, Onehunga, Auckland 1061
  • Cause
    Biomet 3i has identified a visually observable condition which may be present on a limited number of the above 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 lot of packaging cylinders was used in the packaging of the 4 implant lots., the condition does not meet the cleanliness specification of biomet 3i. the residual machining fluid causes the implants to be discolored. although the residual machining fluid is not a health hazard, the discolored implant is visually unacceptable to customers and, thus, biomet 3i is removing these suspect implants from the market.
  • Action
    Product to be returned to supplier

Device

Biomet 3i Dental Implants
  • Modèle / numéro de série
    Model: Catalogue Numbers: BOST3211, Affected: Lots: 2014051395, 2014051817
  • Manufacturer
    Implant Innovations Inc

Manufacturer

Implant Innovations Inc
  • 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
    NZMMDSA