Events

Alerte De Sécurité sur Tibial Alignment Guide – iAssist Knee System

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Zimmer.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2015-05-22
  • Date de publication de l'événement
    2015-05-22
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150522.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: zimmer tibial alignment guide – iassist knee system medical device manufacturer, zimmer, has issued a medical device safety alert concerning tibial alignment guide – iassist knee system. the affected device is identified as follows:- part number : 20-8011-013-00 lot numbers: 120265, 120659, 120659-1, 120793, 110623, 120794, 130134, 130135 based upon complaint investigation, the manufacturer has determined that the potential exists for the spikes on the iassist tibial alignment guide to bend or break during insertion or extraction from the tibia during use. the bending or breakage of the spikes is due to a stress riser at the junction of the spike and the main body of the instrument in combination with the presence of repeated high cyclic bending stresses from the impaction method utilised. these stresses are significantly increased when the proper steps of the surgical technique are not followed. if a spike breaks and goes unobserved, there is the possibility of a spike being left in the surgical site, which may result in a biocompatibility reaction (17-4ph stainless steel not assessed for long term biocompatibility) or interference with magnetic resonance imaging (mri), because of the magnetic stainless steel. the manufacturer is currently making preparations for repair or replacement. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 may 2015.

Device

Tibial Alignment Guide – iAssist Knee System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Zimmer Tibial Alignment Guide – iAssist Knee System
  • Manufacturer
    Zimmer

Manufacturer

Zimmer
  • 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
    DH