Events

Field Safety Notices about BIOLOX FORTE 36mm Alumina ceramic heads

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by MicroPort Orthopedics.

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
  • Date
    2017-02-08
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Microport orthopedics has initiated a voluntary field safety corrective action for biolox forte 36mm alumina ceramic heads. implants will be updated with a label which will state the numerical offset of the ceramic head instead of the current labelling (short, medium, long). the intent of this letter is to inform you of all known risks potentially associated with the use of the products affected by this voluntary field safety corrective action and list any action to be taken by you. .

Device

BIOLOX FORTE 36mm Alumina ceramic heads

Manufacturer

MicroPort Orthopedics