Events

Retiro De Equipo (Recall) de Device Recall Manta Ray" Anterior Cervical Plate (ACP) 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 Integra LifeSciences Corp..

¿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
    58167
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2197-2011
  • Fecha de inicio del evento
    2011-01-10
  • Fecha de publicación del evento
    2011-05-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98587
  • 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, spinal intervertebral body - Product Code KWQ
  • Causa
    Based upon the results of the firm's literature review, they determined that the package insert (information for use) and information in the surgical technique should be revised to include additional warnings, precautions and possible adverse events.
  • Acción
    The firm, Integra Spine, sent an "URGENT: FIELD CORRECTIVE ACTION" letter dated January 10, 2011 with a Field Corrective Action Acknowledgement and Return Form sent via Fed Ex/ priority mail to all customers including physicians and distributors. The letter describes the product, problem and actions to be taken. The customers were instructed to review the current inventory to identify product from the affected part numbers; replace the existing IFU (22-PI-01 rev C) with the revised IFU (22-PI-01 rev D) and the existing Surgical Technique (ST-22-001 rev A) with the revised Surgical Technique (ST-22-001 rev B), and complete and return the Field Corrective Action Acknowledgement and Return Form via fax to: 877-558-6227 or email. If you have any additional questions, contact the Manager Quality Systems Integra Spine at 330-475-8646.

Device

Device Recall Manta Ray" Anterior Cervical Plate (ACP) System
  • Modelo / Serial
    Part Numbers: 22-10-0118, 22-10-0120, 22-10-0122, 22-10-0124, 22-10-0126, 22-10-0128, 22-10-0130, 22-10-0132, 22-10-0134, 22-10-0231, 22-10-0234, 22-10-0237, 22-10-0240, 22-10-0243, 22-10-0246, 22-10-0249, 22-10-0252, 22-10-348, 22-10-0351, 22-10-0354, 22-10-0357, 22-10-0360, 22-10-0363, 22-10-0366, 22-10-0369, 22-10-0372, 22-10-0375, 22-10-0468, 22-10-0472, 22-10-0476, 22-10-0480, 22-10-0484, 22-10-0488, 22-12-4014, 22-12-4015, 22-12-4016, 22-12-018, 22-13-4513, 22-13-4515, 22-13-4517, 22-14-4513, 22-14-4515, 22-14-4517, 22-15-4010, 22-15-4012, 22-15-4013, 22-15-4014, 22-15-4015, 22-15-4016, 22-5-4018, 22-16-4010, 22-16-4012, 22-16-4013, 22-16-4014, 22-16-4015, 22-16-4016, 22-16-4018, 22-17-4513, 22-17-4515, 22-17-4517, 22-18-4513, 22-18-4515, 22-18-4517, 22-20-0118, 22-20-0120, 22-20-0122, 22-20-0124, 22-20-0126, 22-20-0128, 22-20-0130, 22-20-0132, 22-20-0134, 22-20-0231, 22-20-0234, 22-20-0237, 22-20-0240, 22-20-0243, 22-20-0246, 22-20-0249, 22-20-0252, 22-20-0348, 22-20-0351, 22-20-0354, 22-20-0357, 22-20-0360, 22-20-0363, 22-20-0366, 22-20-0369, 22-20-0372, 22-20-0375, 22-20-0468, 22-20-0472, 22-20-0476, 22-20-0480, 22-20-0484, 22-20-0488, 22-20-0492, 22-21-4010, 22-21-4011, 22-21-4012, 22-21-4013 & 22-21-4014.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide distribution: USA including states of: AL, AZ, CA, CO, FL, GA, ID. IL, KS, LA, MD, MO, NH, NM, NV, NY, OH, OK, OR, PA, PR, SD, TN, TX, UT, VA, WI, and WV.
  • Descripción del producto
    Manta Ray" Anterior Cervical Plate (ACP) System, || Intended use: The Manta Ray ACP System is an anterior cervical plate that is indicated for temporary stabilization of the cervical spine from C2-C7.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.