Events

Rappel de Zimmer Air Dermatome II Handpiece (used during skin grafting surgeries)

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-2016-RN-00976-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-25
  • 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-2016-RN-00976-1
  • 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 surgical has received product complaints reporting that the surface coating applied to the device is blistering, peeling and discolouring after usage over time. there have been no injuries associated with the reported complaints. in addition, an independent assessment determined that the blistering, peeling and potentially flaking of the surface coating is not expected to result in any long range health consequences. given that the frequency of this surface coating condition can worsen with age, zimmer biomet is currently making preparations for replacement activities to follow in order to prevent future complaints.
  • Action
    Zimmer is advising users to inspect the devices before and after each use. If blistering or peeling is observed, discontinue use of the affected device. If an alternative device is not available, at the surgeon's discretion, determine the use of the device as a medical necessity and continue to use. After use, follow the facilities wound irrigation protocol or Zimmer Biomet recommends copious irrigation with a normal saline solution or immersion of the graft in a bowl of normal saline. Zimmer Biomet recommends irrigating the donor site with saline as well. Carefully examine the skin graft and donor site for grey coating flakes and continue to irrigate as necessary. All affected devices will be replaced with unaffected stock when available. This action has been closed out on 20/01/2017.

Device

Zimmer Air Dermatome II Handpiece (used during skin grafting surgeries)
  • Modèle / numéro de série
    Zimmer Air Dermatome II Handpiece (used during skin grafting surgeries)Item Number: 00-8851-001-00All serial numbers affectedARTG Number: 115929
  • 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