Events

Retiro De Equipo (Recall) de Device Recall Integra Leyla Ball Joint Clamp

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
    65824
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2056-2013
  • Fecha de inicio del evento
    2013-07-17
  • Fecha de publicación del evento
    2013-08-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120309
  • 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
    Drills, burrs, trephines & accessories (manual - Product Code HBG
  • Causa
    As a result of complaint investigations it was identified that there is a potential that the leyla ball joint clamp (r2383) may not provide the level of stability needed to maintain retraction in all cases.
  • Acción
    Integra sent an Urgent Medical Device letter dated July 17, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to review your inventory and determine if you have any of the affected products. If so, stop using them immediately and remove them from your service. When your form is received, Customer Service will you an RMA number and directions for returning the products. Should you have any questions regarding these instructions, please contact Integra Customer Service at 1-800-997-4868.

Device

Device Recall Integra Leyla Ball Joint Clamp
  • Modelo / Serial
    Catalog Number R2383 and as a component of catalog number R2385, including all lot numbers date codes going back to January 2006.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including Puerto Rico and the states of AZ, CA, FL, GA, IL, IN, KY, MA, MI, MS, NE, NM, NY, OH, PA, TN, TX, UT, VA, WA, WI and WV., and the countries of Spain, Singapore, South Africa, Canada, Libya,Pakistan and Cayman Islands.
  • Descripción del producto
    Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. || The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open during neurosurgery.
  • Manufacturer
    Integra Limited

Manufacturer

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