Events

Alerta De Seguridad para Aiming Arm 125° and Aiming Arm 130° for TFN-ADVANCED (TFNA) System

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
    2015-03-11
  • Fecha de publicación del evento
    2015-03-11
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150311b.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 gmbh aiming arm 125° and aiming arm 130° for tfn-advanced (tfna) system medical device manufacturer, synthes gmbh, has issued a field safety notice concerning aiming arm 125°for static distal locking (03.037.014) and aiming arm 130° for static distal locking (03.037.013), which are a part of the tfn-advanced (tfna) system. the aiming arms are used with various instruments to assist in the proper alignment of tfna. below are the details of the affected lot products: for aiming arm 125° for static distal locking (03.037.014), the affected lot numbers are 8834516, 8883082, 8909986 for aiming arm 130° for static distal locking (03.037.013), the affected lot numbers are 8803637, 8868571, 8877565, 8903839 the manufacturer discovered that during blade insertion, the tfna guide sleeve has the potential to jam inside of the affected aiming arms which may delay disassembly and/or removal of the instruments. the manufacturer advises users to follow the steps mentioned in the field safety notice to address any occurrences of jamming. the manufacturer is in the process of developing the replacement and recovery plan for indicated devices. 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 11 march 2015.

Device

Aiming Arm 125° and Aiming Arm 130° for TFN-ADVANCED (TFNA) System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Synthes GmbH Aiming Arm 125° and Aiming Arm 130° for TFN-ADVANCED (TFNA) System
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH