Events

Retiro De Equipo (Recall) de Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007

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 Synthes USA HQ, 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
    63446
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0277-2013
  • Fecha de publicación del evento
    2012-11-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113797
  • 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
    Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
  • Causa
    The insert provided with the product for the specific lot number indicates that this product is mr safe. this product is mr conditional and is etched as mr conditional. the insert is incorrect.
  • Acción
    Synthes sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated September 28, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were asked to complete and return a Verification Form via fax to 610-251-9005. Contact the firm at 610-719-5450 for questions regarding this notice.

Device

Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007
  • Modelo / Serial
    Part number 390.007, Lot number 6800599
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution-including the states of CA, MN, NC, and TN.
  • Descripción del producto
    Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. || Intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: Stabilization of soft tissues and fractures; Polytrauma/multiple orthopedic trauma; Vertically stable pelvic fractures, or as treatment adjunct for vertically unstable pelvic fractures; Arthrodeses and osteotomies with soft tissue problems - failures of total joints; Neutralization of fractures stabilized with limited internal fixation; Non-unions/septic non-unions; Intra-operative reductions/stabilization tool to assist with indirect reduction; and Unilateral rectilinear bone segment transport or leg lengthening.
  • Manufacturer
    Synthes USA HQ, Inc.

Manufacturer

Synthes USA HQ, Inc.
  • Dirección del fabricante
    Synthes USA HQ, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA