Events

Recall of C-Tech Closed Tray Impression Transfer Implants

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by C-Tech Implant Srl.

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
    15588
  • Event Initiated Date
    2014-09-30
  • 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: Aluro Healthcare NZ, 36a Arrenway Drive, Mairangi Bay, Auckland
  • Reason
    The manufacturer advises the hexagon of the transfer device is not in the right position. this can cause a problem during the realization of the prosthesis as the impression is not perfect.
  • Action
    Product to be returned to supplier

Device

C-Tech Closed Tray Impression Transfer Implants
  • Model / Serial
    Model: Models: BL-4540 & BL-4540L, Affected:
  • Manufacturer
    C-Tech Implant Srl

Manufacturer

C-Tech Implant Srl