Events

Recall of Smith & Nephew Osteotome

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Smith & Nephew 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
    21690
  • Event Initiated Date
    2017-07-14
  • 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: Smith & Nephew Surgical Ltd, Unit A 36 Hillside road, Wairau Valley, AUCKLAND 0760
  • Reason
    The manufacturer has become aware that the affected devices are labelled with expiration dates based on a 10 year packaging shelf-life where the actual validated shelf life of the outer pouch packaging is 5 years. this could potentially result in the outside of the inner tray packaging being non-sterile, potentially contaminating the sterile field.
  • Action
    Product to be exchanged

Device

Smith & Nephew Osteotome
  • Model / Serial
    Model: , Affected: Thin and Radial Osteotome Blades (Model and Batch specific)
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

Smith & Nephew Inc