Events

Retiro De Equipo (Recall) de Device Recall Concorde Lift

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 DePuy Orthopaedics, 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
    79072
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0848-2018
  • Fecha de inicio del evento
    2017-07-26
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161276
  • 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
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • Causa
    Potential for intra-operative breakage of driver tips.
  • Acción
    On August 1, 2017, an Urgent Product Recall notice titled "CONCORDE LIFT DRIVER Driver Shaft and Torque Handle" was mailed to customers that received the affected instruments. The letter described the issue, potential hazard, and actions to be taken. The notice instructs customers to cease further distribution or use and to contact a DePuy Synthes Spine sales consultant to return the products subject to recall. Customers are to review, complete, sign, and return the business reply form provided to the firm within 5 business days of receipt of the notification. A copy of the notice should be forwarded to all staff that need to be informed, as well as, any facility that the affected device was further distributed to. Customers should direct any questions regarding this recall to their DePuy Synthes Spine Sales Consultant or the Clarke Madigan, DePuy Synthes Spine Recall Coordinator, at 508-828-609 or DPYUS-SpineFieldActions@its.jnj.com.

Device

Device Recall Concorde Lift
  • Modelo / Serial
    Product code: 287804101G Lot number: 052316-A R, 121416-A R
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Concorde Lift Driver Shaft AO. || Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
  • Manufacturer
    DePuy Orthopaedics, Inc.

Manufacturer

DePuy Orthopaedics, Inc.
  • Dirección del fabricante
    DePuy Orthopaedics, Inc., 325 Paramount Dr, Raynham MA 02767-5199
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA