Events

Recall of Stryker Instruments (USA) - IIa - 45518 - Saw blade, surgical, powered, sagittal

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
    20554
  • Event Initiated Date
    2016-08-23
  • 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 seal between the top and base rollstock material of the product packaging may not have been manufactured correctly resulting in a sterile barrier breach. due to a breach in sterility, there is a potential for a bone or soft tissue infection which may require medical or surgical intervention.
  • Action
    Product to be returned to supplier

Device

Stryker Instruments (USA) - IIa - 45518 - Saw blade, surgical, powered, sagittal
  • Model / Serial
    Model: Sagittal Blade 18x0.97x90mm, Affected: 16029017
  • Manufacturer
    Stryker Instruments

Manufacturer

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