Events

Safety Alert Or Field Safety Notices for Standard Offset Cup Impactor

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Greatbatch Medical.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2014/031
  • Event Number
    CON437749
  • Date
    2014-07-24
  • Event Date Posted
    2014-07-24
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON437749?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Potential for infection from inadequately sterilized devices. the manufacturer has validated new sterilization parameters for these devices to address this issue. these parameters are provided in the manufacturer’s field safety notice (fsn) issued in march 2014. greatbatch originally sent a notification in january 2014, with one acceptable sterilization parameter, (validated to a sterility assurance level (sal) of at least 10-6). greatbatch has now validated an additional sterilization parameter for use with their device. both acceptable parameters are provided in the updated fsn dated march 2014. the mhra is issuing this medical device alert to ensure that all users are aware of the manufacturer’s updated fsn.
  • Action
    Identify affected devices. Follow the updated sterilization instructions described in the FSN. All staff involved in sterilization of these devices. All orthopaedic staff that use these devices.

Device

Standard Offset Cup Impactor
  • Model / Serial
  • Product Description
    Greatbatch Medical: Standard Offset Cup Impactor
  • Manufacturer
    Greatbatch Medical

Manufacturer

Greatbatch Medical