Retiro De Equipo (Recall) de ENDOFUSE(R) Fusion Rods

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
  • 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
    Screw, fixation, bone - Product Code HWC
  • Causa
    Two lots- one lot of endo-fuse fusion rod, 7x50mm was commingled one lot of endo-fuse(r) fusion rod, 7x70mm. not all parts in each lot are affected. the commingled rod sizes might not be detected prior to surgery.
  • Acción
    The firm, Wright Medical, sent an "URGENT: Medical Device Voluntary Recall" letter dated May 6, 2011 to their customers via FedEx . The letter describes the product, problem, and actions to be taken. The customers were instructed to examine their inventory for the affected products; immediately return any affected product to Wright Technology as soon as possible (contact Customer Service at 800-238-7117 for return instructions and replacement inventory), and immediately complete and return the attached response form via fax to: 901-867-7401. If you have any questions regarding this matter, please contact 800-874-5630.


  • Modelo / Serial
    Lot Number 0886054225, Reference #500005970
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide distribution: USA including states of: AL, AZ, CA, CO, FL, ID, IN, IL, LA, MI, MN, MO, NC, NE, NH, NY, OH, PA, SC, TN, TX, VA, VT, WA, and WI.
  • Descripción del producto
    ENDO-FUSE(TM) FUSION ROD, 7 mm X 70 mm IMPLANT MATERIAL: STERILE R, Ti6A14V, CPTi, REF: 500005970, LOT 088605422, Wright Medical Technology, Inc , 5877 Airline Road, Arlington, TN 38002 || The ENDO-FUSE(R) Intra-Osseous Fusion Rods are indicated for the reduction and fixation of fractures. They are indicated for the integral fixation of fractures, bony fusions, and non-unions. They are also indicated for reconstructive procedures where reduction and fixation of bone fragments are required (e.g. osteotomies).
  • Manufacturer


  • Dirección del fabricante
    Wright Medical Technology Inc, 5677 Airline Rd, Arlington TN 38002-9501
  • Empresa matriz del fabricante (2017)
  • Source