Events

Field Safety Notices about DePuy Sigma HP FB Tibial Tray Impactor

According to Swedish Medical Products Agency, this field safety notices involved a device in Sweden that was produced by Enztec Ltd / DePuy International Ltd.

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
    Field Safety Notice
  • Event ID
    444:2011/81565
  • Event Country
    Sweden
  • Event Source
    SMPA
  • Event Source URL
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2014/Flergangsprodukter--DePuy-Sigma-HP-FB-Tibial-Tray-Impactor--Enztec-Ltd--DePuy-International-Ltd1/#
  • Notes / Alerts
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products 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 data from the U.S. and Sweden.
  • Extra notes in the data
    DINT17202
  • Action
    Products should be withdrawn. The manufacturer has been informed of a dangerous situation that could occur at knäimplantationsoperationer when the product is used. The instrument can be caught in a component of the implant system and this can lead to complications during surgery. The MPA recommends that DePuy Sweden c / o Johnson & Johnson AB is contacted with any questions.

Device

DePuy Sigma HP FB Tibial Tray Impactor

Manufacturer

Enztec Ltd / DePuy International Ltd
  • Source
    SMPA