Avis De Sécurité sur trial femoral head dia.40mm

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Limacorporate spa.

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
    2016-09-12
  • Pays de l'événement
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    This notice needs to be passed on all those who need to be aware within Your organization, or to any organization where the potentially affected devices have been transferred. This Field Safety Notice will be sent to the Competent Authorities of the Countries involved (Italia, Slovenia and Spain). // FSCA ID: 9095.10.744
  • Cause
    An internal analysis performed in limacorporate showed a slight dimensional anomaly on the female taper of the trial femoral heads dia.40mm (product code 9095.10.744) with specific lot # 15am0af. in detail, on a total of 39 trial heads measured with lot # 15am0af, 12 of these trial heads showed a slight over-dimensioning of the female taper diameter. if present, this slight dimensional anomaly may cause an instable coupling between the trial head (female taper) and the trial neck (male taper) intra-operatively, when the surgeon uses these trial devices in order to define the correct size of the final hip implant. limacorporate did not receive any complaint on the lot # 15amoaf. therefore this recall action is a preventive action.

Device

  • Modèle / numéro de série
    15AM0AF
  • Description du dispositif
    Trial device for hip prosthesis
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Via Nazionale, 5233038 Villanova di San Daniele Udine - Italy T. +39 0432 945511 F. +39 0432 945512 info@limacorporate.com www.limacorporate.com • REA Nr. 173824 Cap. Soc. Euro 09.837.283,00 i.v. C.F. e P.IVA IT01427710304
  • Société-mère du fabricant (2017)
  • Source
    AMPMDRS