Events

Rappel de Zimmer Trabecular Metal Reverse Shoulder System

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 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
    15670
  • Date de mise en oeuvre de l'événement
    2013-11-20
  • 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
    Manufacturer launced the zimmer trabecular metal reverse shoulder system in 2006, with over 30,000 sold since launch. during the last 7 years, zimmer has received 90 complaints related to the glenosphere disassociating from the base plate or difficulty assembling the glenosphere to the base plate. this represents a complaint rate of approximately 0.27% since the product was introduced. based on the investigation of these complaints, zimmer determined that additional instructions specific to the assembly of the glenosphere to the base plate were necessary in order to emphasize important techniques. as a result, zimmer updated the applicable surgical technique and also released an instructional video specific to the assembly of the glenosphere. zimmer are providing instructional video specific to the assembly of the glenosphere.
  • Action
    Instructions for use to be updated

Device

Zimmer Trabecular Metal Reverse Shoulder System
  • Modèle / numéro de série
    Model: , Affected: 00-4349-036-11, 00-4349-038-11 and 00-4349-040-11
  • Manufacturer
    Zimmer Inc

Manufacturer

Zimmer 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