Events

Recall of Integra Achillon - Achilles Tendon Suture System

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

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
    20297
  • Event Initiated Date
    2016-06-21
  • 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: Integra Neurosciences Pty Ltd (NZ), 5B Suite B, 331 Rosedale Road, Albany, Auckland 0632
  • Reason
    There is a possibility that one section of the outer package tyvek seal for the achillon® suture system may not remain completely sealed if not used within its shelf-life. the labeled product shelf-life is 5 years.
  • Action
    Product to be returned to supplier

Device

Integra Achillon - Achilles Tendon Suture System
  • Model / Serial
    Model: 119700ND, Affected: All Lots
  • Manufacturer
    Newdeal SAS

Manufacturer

Newdeal SAS