Events

Retiro De Equipo (Recall) de Neoss Guide – Drill-Hubs I to V included in Neoss

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Neoss Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-00917-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-09-21
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00917-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    These batches of drill-hub i may not be functioning as intended (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.No incidents have been reported in australia.
  • Acción
    Customers are asked to inspect their stock on hand and to quarantine affected units prior to their return to Neoss as per the instructions in the Customer Letter.

Device

Neoss Guide – Drill-Hubs I to V included in Neoss
  • Modelo / Serial
    Neoss Guide – Drill-Hubs I to V included in NeossGuide Kit Ø3.5 - Ø4.5 (art no 51153) Identifier #9040Batch Number: 15182, 15586, 16030ARTG Number: 119446
  • Manufacturer
    Neoss Australia Pty Ltd

Manufacturer

Neoss Australia Pty Ltd