Events

Recall of Stryker burs: Round Fluted Soft Touch 3.omm, Neuro Drill 3.0mm, Round Fluted Bur 1.0mm

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

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
    16763
  • Event Initiated Date
    2014-05-29
  • 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
    The manufacturer advises that in approx 1:1000 cases the not feature of the product is only partically present or is entrely missing. . "missing notches" indicates that there are fewer than the normally expected number of notches. "partial notches" indicates that one notch is incomplete because it was begun too close to the end of the shank to allow for a full width notch. a product with "no notches" will have a smooth shank, with no notching.
  • Action
    Product to be exchanged

Device

Stryker burs: Round Fluted Soft Touch 3.omm, Neuro Drill 3.0mm, Round Fluted Bur 1.0mm
  • Model / Serial
    Model: Models: 5820010130, 5820107030, 5820010010, Affected: Lots, 13346027, 14007017 & 13351017, 14005017
  • Manufacturer
    Stryker Instruments

Manufacturer

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