Events

Alerte De Sécurité sur Sternalock Blu Implant Tray

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

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
    2012-01-26
  • 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_20120126b.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
    Field safety notice: biomet microfixation sternalock blu implant tray health canada has issued a type i recall concerning sternalock blu implant tray [model no.: 73-1300, 73-1301, 73-1302; lot no.: 032211, 042911, 100611, 249640, 280130, 280131, 312560, 031411, 011411], manufactured by biomet microfixation, inc. according to the report, the screw measuring area seemed inaccurate and could cause the incorrect screw to be chosen by the medical professionals. it is possible that the screw could come into contact with the lung, heart muscle, or an artery and this could result in a pneumothorax or bleeding. for details, please refer to the health canada website: http://hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/ _list/rec-ret_md-im_date_jan-mar_2012-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Sternalock Blu Implant Tray
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Biomet Microfixation Sternalock Blu Implant Tray
  • Manufacturer
    Biomet Microfixation

Manufacturer

Biomet Microfixation
  • 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