Events

Rappel de Zimmer Femoral Heads and Taper

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 Zimmer GmbH.

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
    17989
  • Date de mise en oeuvre de l'événement
    2015-01-22
  • 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: Zimmer Biomet New Zealand Company, 210 Khyber Pass Road, Grafton, Auckland
  • Cause
    Zimmer identified a subset of products that were manufactured prior to mid-2012 and packaged in a specific configuration that failed a packaging test due to potential compromise of the inner sterile tray. this packaging configuration consists of a double sterile barrier. there are no known incidents where the outer tray was compromised; therefore the device remains sterile when delivered during surgery. this recall is not related to sterility concerns, but rather the removal of any unconsumed product given that the packaging may not have the double sterile barrier as intended.
  • Action
    Product to be returned to supplier

Device

Zimmer Femoral Heads and Taper
  • Modèle / numéro de série
    Model: 32 models, Affected: Product distributed between May-2005 through Nov-2014
  • Manufacturer
    Zimmer GmbH

Manufacturer

Zimmer GmbH
  • 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