Recall of Stryker Exeter Non V40 Rasp Handle

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

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
    20400
  • Event Initiated Date
    2016-07-14
  • 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
    There have been instances where a rivet or rivets have come off an exeter non v40 rasp handle. these instances are associated with the exeter rasp handles with either the green or black plastic lever, manufactured between january 1995 and october 2005. the design was updated in 2005.
  • Action
    Product to be returned to supplier

Device

  • Model / Serial
    Model: Exeter Non V40 Rasp Handle / 0930-9-003, Affected: All Rasps Handles with Plastic Lever
  • Manufacturer

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    NZMMDSA