Retiro De Equipo (Recall) de Device Recall MANI Needle and Suture Pack PGA Absorbable

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 Mani, Inc. - Kiyohara Facility.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
  • Causa
    Surgical sutures may be weak and may not function as intended during surgical procedures.
  • Acción
    The manufacturer notified consignees by phone, via fax with a letter, and e-mail on 07/20/11. The letter asked customers to check their inventory for any of the affected product, and if they had any product remaining to place the amount in the list "Returned." If there was no product left, then the amount used should be placed in the list "Used." Customers needed to complete and sign the document, being sure to send it and any remaining product to the address provided. Credit would be issued once goods were received. If customers have questions, they should contact the firm.


  • Modelo / Serial
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution -- PA and FL.
  • Descripción del producto
    MANI Needle and Suture Pack, 5-0 PGA Absorbable, Model 3391, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan*** || For use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
  • Manufacturer


  • Dirección del fabricante
    Mani, Inc. - Kiyohara Facility, 8-3 Kiyohara Industrial Park, Utsunomiya-shi, Tochigi-ken Japan
  • Empresa matriz del fabricante (2017)
  • Source