Events

Retiro De Equipo (Recall) de Device Recall Soft Face "No Bounce" Mallet

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Signal Medical Corporation.

¿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
    76509
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1834-2017
  • Fecha de inicio del evento
    2017-02-20
  • Fecha de publicación del evento
    2017-04-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-08-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153400
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Mallet, surgical, general & plastic surgery - Product Code GFJ
  • Causa
    Potential for poly tip of the mallet to come off during use. potential for foreign material in the surgical field or delay in surgery. reminder for customers that the poly tip must be removed for cleaning and sterilization to assure proper cleaning and sterilization of the entire mallet.
  • Acción
    On 2/20/2016, URGENT: MEDICAL DEVICE RECALL notifications dated February 10, 2017 were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers are to retain the notice and replace the old Instructions For Use with the updated version. Also, they are to acknowledge receipt of the instructions by signing the notice and emailing to SignalMedical2017@gmail.com or faxing to 810-364-7072. The firm has attached the revised labeling to the letter.

Device

Device Recall Soft Face "No Bounce" Mallet

Manufacturer

Signal Medical Corporation
  • Dirección del fabricante
    Signal Medical Corporation, 400 Pyramid Dr, Marysville MI 48040-2463
  • Empresa matriz del fabricante (2017)
    Signal Medical Corporation
  • Source
    USFDA