Events

Retiro De Equipo (Recall) de Device Recall Kwire, Smooth Doublepointed 0.8 x 90mm

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 Integra LifeSciences Corp..

¿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
    74224
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2084-2016
  • Fecha de inicio del evento
    2016-05-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146870
  • 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
    Passer, wire, orthopedic - Product Code HXI
  • Causa
    The affected k-wires do not meet specification requirements. specifically, a) k-wires were made of 316lvm stainless steel instead of 304 stainless steel. b) k-wires have passivated surface finish instead of electro-polish surface finish. c) k-wires have incorrect length and diameter.
  • Acción
    Integra sent an Urgent Voluntary Medical Device Recall letter dated May 20, 2016, to all affected consignees regarding the recall via traceable courier service. The letter identified the product, the problem, and the action to be taken by the customer. Customers who have supplied affected product should forward a copy of the Recall Notice to them. Customers should review their inventory for affected product, complete the form as to whether they have any affected product or not, return the form by email or fax as indicated on the form. Customers with questions should contact Customer Service at 1-800-654-2873. For questions regarding this recall call 609-936-6822.

Device

Device Recall Kwire, Smooth Doublepointed 0.8 x 90mm
  • Modelo / Serial
    Lot 237830TE
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to OK, CA, TX, WA, GA, NY, MS, NY, PA
  • Descripción del producto
    K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System || The K-wire is used in conjunction with the 2.0 mm cannulated screws for the METASURG Capture Screw System. The K-wire is used by the physician to insert into the bone and to act as a guide for drilling, countersinking and installing screws
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.