Events

Alerta De Seguridad para Bending/Cutting Pliers with Nose for LOCK Plates 2.0

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
    2014-12-19
  • Fecha de publicación del evento
    2014-12-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141219.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 bending/cutting pliers with nose for lock plates 2.0 medical device manufacturer, synthes gmbh, has issued a medical device safety alert concerning its bending/cutting pliers with nose for lock plates 2.0 [part number: 329.143; lot number: multiple]. the manufacturer is initiating a voluntary medical device recall of the abovementioned device, which is intended to be used for bending and/or cutting compact 2.0 mandible locking plates. the affected lots of the bending/cutting pliers with nose for lock plates 2.0 have the potential for tip breakage while bending the extra-large compact 2.0 mandible locking plates. the manufacturer advises affected users to immediately identify and quarantine all unused affected 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 19 december 2014.

Device

Bending/Cutting Pliers with Nose for LOCK Plates 2.0
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Synthes GmbH Bending/Cutting Pliers with Nose for LOCK Plates 2.0
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH