Events

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

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Neoss 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
    19204
  • Fecha de inicio del evento
    2015-09-29
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Neoss Australia Pty Ltd (NZ), 61 Penney Ave, Mt Roskill, Auckland 1041
  • Causa
    Specific 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.
  • Acción
    Product to be returned to supplier

Device

Neoss Guide - Drill hubs I to V included in Neoss Guide Kit
  • Modelo / Serial
    Model: 51153, Affected: 15182, 15586, 16030
  • Manufacturer
    Neoss Ltd

Manufacturer

Neoss Ltd
  • Empresa matriz del fabricante (2017)
    Neoss Ltd.
  • Source
    NZMMDSA