Events

Rappel de Vanguard Open Box Posterior Stabilised Femoral Components

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 Biomet 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-2017-RN-00984-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-10
  • 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-2017-RN-00984-1
  • 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 biomet has identified an issue with vanguard open box posterior stabilised femoral components where inadequate line clearance at the supplier between 5 april 2016 and 1 september 2016. as a result, the packaging of some femoral components was incorrectly labelled as either smaller or larger and/or as the incorrect side (right/left). it is highly detectable at the point of use that the device was incorrectly labelled. the estimated rate of occurrence is <1 in 1,000 products.
  • Action
    Zimmer is requesting surgeons: 1. Review the notification and ensure affected personnel are aware of the contents; 2. Complete the Certificate of Acknowledgement supplied with the customer letter, then a. Return a copy to RAQA.ANZ@zimmerbiomet.com; and b. Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation. 3. If after reviewing this notice there are further questions or concerns please contact the local Zimmer Biomet representative.

Device

Vanguard Open Box Posterior Stabilised Femoral Components
  • Modèle / numéro de série
    Vanguard Open Box Posterior Stabilised Femoral ComponentsItem Number :183106Lot Number: J3842173Item Number: 183106Lot Number: J3844489ARTG Number: 218510
  • Manufacturer
    Zimmer Biomet Pty Ltd

Manufacturer

Zimmer Biomet 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