Events

Alerte De Sécurité sur Neoss Guide – Drill-Hubs I to V included in Neoss Guide Kit

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

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
    2015-09-23
  • Date de publication de l'événement
    2015-09-23
  • 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_20150923c.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: neoss guide – drill-hubs i to v included in neoss guide kit the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning neoss guide – drill-hubs i to v included in neoss guide kit ø3.5 - ø4.5 (art number 51153), manufactured by neoss. the affected product identifier is 9040, with product numbers (bn) 15182, 15586 and 16030. according to the alert, the affected batches of drill-hub i may not be functioning as intended. specifically, the drill does not latch completely in the drill-hub i. the upper part of the bore in the drill-hub i is slightly smaller which results in the drill not being seated correctly which means that this drill-hub will drill deeper than intended, this could lead to permanent damage of the alveolar nerve and cause permanent loss of sense in parts of the oral cavity or chin or even partial loss of speech. there is also a risk of drill loosening or not rotating as expected. the manufacturer advises affected users to inspect their stock on hand and to quarantine affected units prior to their return to the manufacturer. for details, please refer to the tga websites:http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00917-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 september 2015.

Device

Neoss Guide – Drill-Hubs I to V included in Neoss Guide Kit
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Neoss Guide – Drill-Hubs I to V included in Neoss Guide Kit
  • Manufacturer
    Neoss

Manufacturer

Neoss