Events

Retiro De Equipo (Recall) de Millennium Surgical, Boss Instruments, Stealth Surgical, CareFusion

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 Instrumed International, Inc..

¿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
    69471
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0553-2015
  • Fecha de inicio del evento
    2014-09-08
  • Fecha de publicación del evento
    2014-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-11-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131348
  • 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
    Tong, skull for traction - Product Code HAX
  • Causa
    The reason these devices are being withdrawn from the market by instrumed is that instrumed did not market these devices prior to september 26, 1976, and therefore, does not meet all fda requirements to market the devices as "pre-amendment" devices.
  • Acción
    Instrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers. The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119.

Device

Millennium Surgical, Boss Instruments, Stealth Surgical, CareFusion
  • Modelo / Serial
    1) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed Product Number: 638-05421; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Titanium Fixation Screw Springloaded, Each; Millennium Surgical Item Number: 6-1944TS; Lot Numbers: 100512, 110313.   2) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed Product Number: 638-05421; Trade Name: Boss Instruments; Boss Instruments Product Name: Titanium Fixation Screw Springloaded, Each; Boss Instruments Item Number: 74-0184T; Lot Numbers: 020512, 100512.   3) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed Product Number: 638-05421; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Titanium Fixation Screw Springloaded, Each; Stealth Surgical Item Number: SS2193AT; Lot Number: 020512.   4) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed Product Number: 638-05421; Trade Name: CareFusion; CareFusion Product Name: Titanium Fixation Screw Springloaded, Each; CareFusion Item Number: VM85-12955; Lot Number: 050314, 110211, 110313.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
  • Descripción del producto
    Titanium fixation screws, springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the Millennium Surgical, Boss Instruments, Stealth Surgical, and CareFusion brand names.
  • Manufacturer
    Instrumed International, Inc.

Manufacturer

Instrumed International, Inc.
  • Dirección del fabricante
    Instrumed International, Inc., 626 Cooper Ct, Schaumburg IL 60173-4537
  • Empresa matriz del fabricante (2017)
    Avalign Technologies Inc.
  • Source
    USFDA