Events

Rappel de Various Sterile-Packaged Femoral Heads (Various sizes, neck lengths and taper sizes)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Zimmer Pty Ltd.

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
    RC-2015-RN-00029-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-01-29
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00029-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Zimmer identified a subset of products that were manufactured prior to june -2012 and packaged in a specific configuration that failed packaging design verification 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. this recall is initiated to remove any unconsumed product given that the packaging may not have the double sterile barrier as intended.
  • Action
    Zimmer is requesting their customers to quarantine the affected product. Zimmer is arranging for the collection of the product through their sales representative. This action has been closed-out on 24/05/2016.

Device

Various Sterile-Packaged Femoral Heads (Various sizes, neck lengths and taper sizes)
  • Modèle / numéro de série
    Various Sterile-Packaged Femoral Heads (Various sizes, neck lengths and taper sizes)Multiple Item Numbers and Lot NumbersManufactured prior to June-2012 and distributed from May 2005 through November 2014ARTG Numbers: 215999, 216181 & 99906
  • Manufacturer
    Zimmer Pty Ltd

Manufacturer

Zimmer Pty Ltd
  • 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
    DHTGA