Field Safety Notices about Surgical Technique uCentum™ comprehensive posterior system open and percutaneous

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 ulrich 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
    Field Safety Notice
  • Event Country
  • Event Source
  • 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
    We find out that the locking screw cs 3801-01 fit to both sides to the screwdriver tip for locking screws, self-retaining cs 3851-01. the fixation however is only correct from the top side of the locking screw, being easily identified. therefore the ucentum surgical technique open and percutaneous in the step screwing in the locking screw cs 3801- 01 in "instrumentation using polyaxial and monoaxial screws" will be specified. .


  • Model / Serial
    CS 3801-01 – Locking Screw – All LOTs
  • Manufacturer