Events

Retiro De Equipo (Recall) de Device Recall CLAW(R) PLATE 20mm INTERAXIS CHARLOTTE(R) F&A; SYSTEM

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 Wright Medical Technology, 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
    69058
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2599-2014
  • Fecha de inicio del evento
    2014-07-30
  • Fecha de publicación del evento
    2014-09-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129459
  • 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
    Plate, fixation, bone - Product Code HRS
  • Causa
    Plates manufactured from an incorrect raw material.
  • Acción
    Wright Medical sent an Urgent Medical Device Recall letter dated July 25, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory for the affected product and immediately quarantine all affected product and return to Wright Medical as soon as possible. For return instructions customers were instructed to contact Customer Service at 800-238-7117. Customers were also asked to complete the attached response form, confirming receipt of the notice and the status of the product(s) on hand and return by fax to 901-867-7401. Customers with questions were instructed to call 901-290-5662. For questions regarding this recall call 800-238-7117.

Device

Device Recall CLAW(R) PLATE 20mm INTERAXIS CHARLOTTE(R) F&A; SYSTEM
  • Modelo / Serial
    Lot Number: 1543488
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France.
  • Descripción del producto
    CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A; SYSTEM, REF 40S20020, 1 EACH, Rx ONLY, NON STERILE || Orthopedic
  • Manufacturer
    Wright Medical Technology, Inc.

Manufacturer

Wright Medical Technology, Inc.
  • Dirección del fabricante
    Wright Medical Technology, Inc., 1023 Cherry Rd, Memphis TN 38117-5423
  • Empresa matriz del fabricante (2017)
    Wright Medical Group NV
  • Source
    USFDA