Events

Recall of Stryker SBi u head stem and sigmoid notch radial stem

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Small Bone Innovations Inc.

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
    18724
  • Event Initiated Date
    2015-06-24
  • 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
    Stryker became aware during laboratory testing that there is a potential that the packaging integrity (sterile barrier) of the packaging type kit i may be compromised by transportation. a compromised sterile barrier could result in the surgeon selecting a back-up device or, if not recognized, an unintended implantation of a potentially non sterile device. the packaging type kit i consists of a white cardboard box, an outer peel pouch, and an inner peel pouch.
  • Action
    Manufacturer to issue advice regarding use

Device

Stryker SBi u head stem and sigmoid notch radial stem

Manufacturer

Small Bone Innovations Inc
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NZMMDSA