Alerta De Seguridad para Sciatic Nerve Retractors

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Synthes GmbH.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: synthes gmbh sciatic nerve retractors medical device manufacturer, synthes gmbh, has issued a medical device safety alert concerning its sciatic nerve retractors. the affected devices are identified as the following:- retractor f/sciatic nerve [part numbers: 03.100.013; lot numbers: t104992, t114599, t140390, t140674, t140675, t140676, t140677, t141539, t143644, t144855, t145296, t145589, t145819, t146660, t147930, t148624, t149725, t149726, t151370, t152806, t152807, t153692, t155648, t156708, t160394, t939640, t987813] retractor f/sciatic nerve long [part number: 03.100.014; lot numbers: t104993, t108115, t114598, t140566, t140665, t140670, t140671, t140673, t141540, t143687, t144854, t145585, t145590, t145932, t146657, t147929, t148552, t148553, t149727, t149728 t151369, t151488, t152808, t152809, t153884, t155649, t958061] the manufacturer is initiating a product removal of the above part and lot numbers of sciatic nerve retractors. these devices are part of the 3.5mm low profile pelvic system and intended for drawing back soft tissue during orthopaedic surgery. according to the manufacturer, there is the potential for micropores to form on the hollow handle of the sciatic nerve retractor. as the pores may increase in size, it is possible that fluids may enter the hollow handle during surgery. thus, even with diligent reprocessing/sterilization of the retractor, subsequent patients may be at risk for infection and adverse tissue reaction due to retained fluids leaking out during use. additionally, if the discoloration and/or moisture are not identified within the packaging of the affected sciatic nerve retractors preoperatively, there is a potential for surgical delay due to the time required to investigate and decide next steps. the users are requested to immediately review their inventory to identify and quarantine the affected products. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 april 2018.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Synthes GmbH Sciatic Nerve Retractors
  • Manufacturer