Field Safety Notices about 048.600 RN synOcta Abutment H2.5mm

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by INSTITUT STRAUMANN.

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 Date Posted
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Extra notes in the data
  • Reason
    Examination of one customer's complaint confirmed that the entire lot of 240 units 048.600 rn synocta abutment h2.5mm lot gj 235 contained information that incorrectly stated 048.612 lot gj040. the survey also confirmed that the aforementioned mistake is limited to this lot only. 91 pieces were distributed to clients maximum. package contains correct abutment 048.600 rn synocta abutment h2.5 mm lot gj235. our risk analysis has shown that incorrect labeling for patients on the packaging will not result in injury or illness to the patient. an incorrect tag is only registered as an error in the documentation in the patient's history file. the consequence of such an error in the documentation is the loss of trace in the event of future actions in the field, related to item 048.600 of gj235.