Events

Field Safety Notices about trial femoral head dia.40mm

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 Limacorporate spa.

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
    2016-09-12
  • 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
    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
  • Reason
    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

trial femoral head dia.40mm
  • Model / Serial
    15AM0AF
  • Product Description
    Trial device for hip prosthesis
  • Manufacturer
    Limacorporate spa

Manufacturer

Limacorporate spa
  • Manufacturer Address
    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
  • Manufacturer Parent Company (2017)
    Emil Holding Ii Sarl
  • Source
    AMPMDRS