Events

Recall of Stryker Leibinger GmbH - MEDPOR Sizer Sets

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Stryker Leibinger GmbH & Co KG.

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
    20999
  • Event Initiated Date
    2017-01-10
  • 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 received a report indicating that the outer label of a medpor sizer set states sterile, whereas the product is actually delivered non-sterile. investigations revealed that additional products and lots have an incorrect sterility status on their labels.
  • Action
    Product to be returned to supplier

Device

Stryker Leibinger GmbH - MEDPOR Sizer Sets
  • Model / Serial
    Model: , Affected: QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/cs), Design M Malar Sizer Set (Silicone, Non-Sterile), Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile)
  • Manufacturer
    Stryker Leibinger GmbH & Co KG

Manufacturer

Stryker Leibinger GmbH & Co KG
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NZMMDSA