Events

Recall of Neoss Guide - Drill hubs I to V included in Neoss Guide Kit

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Neoss Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    19204
  • Event Initiated Date
    2015-09-29
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    Recalling Organisation: Neoss Australia Pty Ltd (NZ), 61 Penney Ave, Mt Roskill, Auckland 1041
  • Reason
    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.
  • Action
    Product to be returned to supplier

Device

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

Manufacturer

Neoss Ltd
  • Manufacturer Parent Company (2017)
    Neoss Ltd.
  • Source
    NZMMDSA