Rappel de Biomet 3i NSK Contra-Angle Torque Driver Kits

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 Biomet 3i.

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
    15292
  • Date de mise en oeuvre de l'événement
    2013-08-30
  • 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
    Biomet 3i recently conducted revised sterilization validation testing on all commercial surgical kits / trays. during these validations, some models of surgical 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
    Instructions for use to be updated

Device

  • Modèle / numéro de série
    Model: Product Codes: NSPDK0, PST1, PSKD0, NCATD0, CATD0, NCATD0C, Affected: All lots
  • 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