Events

Recall of Stryker OtisMed Shapematch Cutting Guides

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
    15262
  • Event Initiated Date
    2013-09-02
  • 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 reason for this hazard alert is multifactorial:, , 1/ the surgical protocol for the shapematch cutting guides did not provide sufficient information on:, the position of the cutting guides,, the need for osteophyte/soft tissue removal,, the requirement for proper axial drilling and, the need to avoid angulation and mal-alignment., , 2/ the approved pre-operative plan did not provide sufficient information regarding the need for osteophyte removal., , 3/ the values displayed via the otismed.Net web portal were inconsistent with the pre-operative planning values used to manufacture some of the shapematch cutting guides.
  • Action
    Manufacturer to issue advice regarding use

Device

Stryker OtisMed Shapematch Cutting Guides

Manufacturer

Stryker Howmedica Osteonics
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NZMMDSA