Events

Alerta De Seguridad para Holding Clamps for Multi Vector Distractor

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

¿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
    2013-04-09
  • Fecha de publicación del evento
    2013-04-09
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130409c.html
  • 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 holding clamps for multi vector distractor medical device manufacturer, synthes, has initiated a field safety corrective action concerning holding clamps for multi vector distractor. the affected part numbers included 487.938, 487.939, 487.940, 487.941 and 487.942. the manufacturer has received two complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. no patient harm was reported. the manufacturer advises the affected users to quarantine the affected products. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 9 april 2013.

Device

Holding Clamps for Multi Vector Distractor
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Synthes Holding Clamps for Multi Vector Distractor
  • Manufacturer
    Synthes

Manufacturer

Synthes