Events

Recall of Novus TIGRR® Matrix Surgical Mesh

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

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
    20455
  • Event Initiated Date
    2016-08-01
  • 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: Clinical & Regulatory Services Limited, 50B Puketapu Road, Taradale, Napier 4112
  • Reason
    The product's instructions for use (ifu) have been updated based on the 3-year follow up of a clinical study. in the study the patients with direct (medial and combined) inguinal hernia showed relative high recurrence rates. the patient group is considered unable to form scar tissue strong enough to replace the mesh, leading to the conclusion that a permanent mesh is required.
  • Action
    Instructions for use to be updated

Device

Novus TIGRR® Matrix Surgical Mesh
  • Model / Serial
    Model: NSTM1015E, NST152OE and NSTM2030E, Affected:
  • Manufacturer
    Novus Scientific AB

Manufacturer

Novus Scientific AB