Events

Rappel de UNIVERSAL Modular Electric/Battery Double Trigger Handpiece (Surgical power tool)

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-01068-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-10-17
  • 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-01068-1
  • 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 surgical identified a potential malfunction on the universal modular electric/battery double trigger handpiece. it is possible that the handpiece could start by itself when the power source is connected. the unexpected output of the device (start by itself) could lead to an injury to the user during usage or preparation of the device. the complaint rate for this occurrence is 0.5% per distributed device, and no injuries have been reported.
  • Action
    To avoid this potential issue (malfunction), Zimmer Surgical is advising customers to implement temporary workaround instructions through the customer letter. Zimmer Surgical, as part of the annual preventive maintenance activities, will upgrade the devices with the new electronics that prevent the “self-start” issue and may also exchange other components as appropriate during the preventive maintenance check. This action has been closed-out on 06/06/2016.

Device

UNIVERSAL Modular Electric/Battery Double Trigger Handpiece (Surgical power tool)
  • Modèle / numéro de série
    UNIVERSAL Modular Electric/Battery Double Trigger Handpiece (Surgical power tool)Model number: 89-8507-400-00ARTG Number 215808
  • 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