Events

Recall of Stryker Target Nano Detachable Coil

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

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
    20257
  • Event Initiated Date
    2016-06-24
  • 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: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Reason
    Some units of the target nano detachable coils do not have the intended stretch resistance. the sutures inside the coil that provide stretch resistance may have been damaged during manufacture which can lead to an increased occurrence of coil stretching. note that this issue relates to the target nano range of detachable coils only.
  • Action
    Product to be returned to supplier

Device

Stryker Target Nano Detachable Coil
  • Model / Serial
    Model: 542102, 542103, 542152, 542153, 542154, 543101, 543102, 543103, 543151, 543152, 543153, 543154, 544203, 544204, 544254, 544304, 544306, 544356, 545202, 545203, 545204, 545206, 545253, 545254, 545256, 545304, 545306, 545308, Affected: Multiple Lots
  • Manufacturer
    Stryker Neurovascular

Manufacturer

Stryker Neurovascular
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NZMMDSA