Events

Rappel de Persona Distal Valgus Alignment Guide (supplied as part of the reusable surgical kit)

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-2014-RN-01028-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-09-26
  • 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-2014-RN-01028-1
  • 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 has received complaints related to binding of the distal valgus alignment guide's locking knob. persona distal valgus alignment guide collet locks are seizing in the 'unlocked' position during normal operation. this seizure causes the diameter between the collet pegs to become smaller than that of the 8mm im (intramedullary) rod and prevents the rod from being inserted or removed from the alignment guide rendering the device unusable. the root cause of the binding was determined to be excessive counter-clockwise rotation of the knob when unlocking the device.
  • Action
    Zimmer determined that additional guidance on the locking/unlocking feature was needed. Zimmer is requesting the customers to review the updated portion of the Persona surgical technique (97-5026-001-00) provided with the customer letter, which details use of the Adjustable Valgus Guide. This action has been closed-out on 07/06/2016.

Device

Persona Distal Valgus Alignment Guide (supplied as part of the reusable surgical kit)
  • Modèle / numéro de série
    Persona Distal Valgus Alignment Guide (supplied as part of the reusable surgical kit)Item number: 42-5099-004-00ARTG number: 109936
  • 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