Events

Retiro De Equipo (Recall) de Device Recall MAYFIELD Horseshoe Gel Pads Left Gel Pad

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 Limited.

¿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
    62711
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2457-2012
  • Fecha de inicio del evento
    2012-07-27
  • Fecha de publicación del evento
    2012-09-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111476
  • 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
    Accessories, operating-room, table (kit) - Product Code FWZ
  • Causa
    An investigation of customer complaints identified that for two product lots, left horseshoe gel pads were packaged as a right horseshoe gel pads and vice versa. none of the complaints resulted in a report of patient injuries or an increase in the time to complete the surgical procedure. a physician was consulted to assess patient risk and concluded that there is no potential harm to patients, onl.
  • Acción
    Integra Lifesciences sent an "URGENTURGENT: VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" letter dated July 27, 2012 to all affected customers. The letter identifies the affected products, problem and actions to be taken by the customers. Customers were instructed to check their inventory for affected products and quarantine them for shipment back to Integra. Customers were asked to complete the Recall Acknowledgement and Return Forms ASAP whether or not they intended on returning any recalled product. Contact Integra Customer Service at 1-877-444-1114, Option 3 for Technical Support.

Device

Device Recall MAYFIELD Horseshoe Gel Pads Left Gel Pad
  • Modelo / Serial
    The Lot No's for the affected Gel Pads are Lot 093990 of part number #440C1012 for Left Gel Pads
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide including the states of AZ, CA, CO, DC, GA, IA, IL, IN, NC, and NY and the countries of: Canada and Belgium.
  • Descripción del producto
    The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. || The Gel Pads are supplied to users in labeled plastic bags, 1 per bag. || Product Usage: || The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. They are plastic gel filled devices that provide cushioning between the head and other metallic part of the MAYFIELD¿ system. The Left and Right Pads are mirror images.
  • Manufacturer
    Integra Limited

Manufacturer

Integra Limited
  • Dirección del fabricante
    Integra Limited, 311 Enterprise Dr, Plainsboro NJ 08536-3344
  • Source
    USFDA