Events

Recall of Ormco VectorTAS Screw, 8mm

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

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
    15080
  • Event Initiated Date
    2013-08-01
  • 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: Law and Accounting Professional Trustees Limited, 336, Jackson Street, Petone
  • Reason
    The manufacturer has determined that some screws in this lot were machined undersized at the top of the threads may potentially cause a weakening of the screw. use of the undersized product may result in breakage of the screw during insertion or removal when torqued, possibly requiring surgical removal of any remaining pieces.
  • Action
    Product to be returned to supplier

Device

Ormco VectorTAS Screw, 8mm
  • Model / Serial
    Model: Part Numbers: 601-0021 & 601-0010, Affected: Lot Number: 112911
  • Manufacturer
    Ormco Corporation

Manufacturer

Ormco Corporation