Events

Recall of Stryker Orthopaedics Duracon Beaded Cruciform Tibial Trays w/ PA

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
    13559
  • Event Initiated Date
    2012-10-04
  • 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
    Manufacturer has become aware of potential packaging issue associated with various products. initial inspections of some items (as listed) revealed what the manufacturer refers to as “creep”. this is when the sterile barrier surface area decreases. at this point, no units have been found to have a full breach of the seal., technical and medical assessments are currently underway to determine any potential hazards associated with the use of the product. all product to be returned to the manufacturer.
  • Action
    Product to be returned to supplier

Device

Stryker Orthopaedics Duracon Beaded Cruciform Tibial Trays w/ PA

Manufacturer

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