Events

Retiro De Equipo (Recall) de Bending/Cutting Pliers with Nose, for LOCK Plates 2.0

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Synthes Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-01359-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-12-23
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01359-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    The pliers have the potential for tip breakage while bending the extra-large compact 2.0 mandible locking plates (part numbers 447.412, 447.420, 447.422, 447.423, 447.424, 447.425, 447.426, 447.412s, 447.420s, 447.422s, 447.423s 447.424 s, 447.425 s and 447.426s ) with the last hole feature of the instrument.If a nonconforming bending/cutting pliers with nose for lock plates 2.0 is used and breaks while in the operating room, surgical delay may occur while alternate bending or cutting instruments are located.To date, there have been no reports of adverse events related to this issue. such reports are unlikely to occur as the bending/cutting pliers with nose for lock plates 2.0 are not used in direct contact with the patient but rather on the plates before they are inserted.
  • Acción
    Customers are requested to:- 1. Check inventory immediately for the affected units; 2. Synthes will contact customers to arrange a replacement or credit as available; 3. An interim inspection procedure had been provided to customers whilst awaiting replacement stock. This action has been closed-out on 14/07/2016.

Device

Bending/Cutting Pliers with Nose, for LOCK Plates 2.0
  • Modelo / Serial
    Bending/Cutting Pliers with Nose, for LOCK Plates 2.0 Part Number: 329.143 Multiple Lot Numbers affectedARTG Number: 153950
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd