Events

Alerta De Seguridad para Cross-Link Clamp for Rods Ø 6.0 mm, preassembled, Titanium Alloy (TAN), dark blue

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por DePuy 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
    2015-03-19
  • Fecha de publicación del evento
    2015-03-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150319.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: depuy synthes cross-link clamp for rods ø 6.0 mm, preassembled, titanium alloy (tan), dark blue medical device manufacturer, depuy synthes, has issued a medical device safety alert concerning cross-link clamp for rods ø 6.0 mm, preassembled, titanium alloy (tan), dark blue [part number: 498.813(s). lot numbers: 2780518, 2781527, 2780516, 2780511, 2780509, 2780507]. due to an error in production, the affected lots cannot be securely attached to the 6 mm longitudinal rods. this may result in surgical delay as the affected device cannot be tightened appropriately during surgery and an alternative device is required. product recall is on-going. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 march 2015.

Device

Cross-Link Clamp for Rods Ø 6.0 mm, preassembled, Titanium Alloy (TAN), dark blue
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: DePuy Synthes Cross-Link Clamp for Rods Ø 6.0 mm, preassembled, Titanium Alloy (TAN), dark blue
  • Manufacturer
    DePuy Synthes

Manufacturer

DePuy Synthes