Rappel de Biomet 3i Bellatek Encode Healing Abutment

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
    19551
  • Date de mise en oeuvre de l'événement
    2015-12-11
  • Pays de l'événement
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
  • 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
    Through investigation, biomet 3i determined that a limited number of product pouches may not have been sealed during packaging. the occurrence rate to date of a pouch not being sealed during packaging is approximately 0.008%. in the event the product pouch is unsealed, the sterility of the product contained within the pouch cannot be assured and/or the component may be missing.
  • Action
    Product to be returned to supplier

Device

  • Modèle / numéro de série
    Model: EHA343, EHA344, EHA346, EHA348, EHA353, EHA354, EHA356, EHA358, EHA443, EHA444, EHA446, EHA448, EHA453, EHA454, EHA456, EHA458, EHA463, EHA464, EHA466, EHA468, EHA473, EHA474, EHA476, EHA478, EHA553, EHA554, EHA556, EHA558, EHA563, EHA564, EHA566, EHA568,, Affected: Expiry dates between Nov-2015 and Nov-2020
  • Manufacturer

Manufacturer

  • Société-mère du fabricant (2017)
  • 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