Events

Avis De Sécurité sur 048.600 RN synOcta Abutment H2.5mm

Selon ALIMS (Agencija za lekove i medicinska sredstva), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Serbia qui a été fabriqué par INSTITUT STRAUMANN.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date de publication de l'événement
    2014-01-07
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    https://www.alims.gov.rs/latin/2014/07/01/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-abutment-tip-rn-synocta-cementable-rn-synocta-angled-rn-synocta-screw-retained-wn-synocta-screw-retained-wn-synocta-cementable-wn/
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.

Device

048.600 RN synOcta Abutment H2.5mm

Manufacturer

INSTITUT STRAUMANN