Recall of Stryker Endoscopy CinchLock SS Knotless Anchor with Inserter

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

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
    20080
  • Event Initiated Date
    2016-04-27
  • Event Country
  • Event Source
    NZMMDSA
  • Event Source URL
  • 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
    Manufacturer had advised that there have been several complaints related to the pull wire breaking since product launch.There were two modes of failure identified for the pull wire:, 1. near the inserter handle and, 2.At the most distal tip where the wire ends with a larger diameter tip.
  • Action
    Product to be destroyed

Device

  • Model / Serial
    Model: CAT02462, Affected: Lot Numbers: 15120801, 15121401, 16010402, 16011901, 16012501
  • Manufacturer

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    NZMMDSA