Events

Retiro De Equipo (Recall) de Device Recall Tibila Insert UC

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 Ortho Development Corporation.

¿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
    68898
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2256-2014
  • Fecha de inicio del evento
    2014-07-11
  • Fecha de publicación del evento
    2014-08-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128978
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Causa
    Ortho development is recalling various pivot bipolar cup, patella, ps tibial insert, uc tibila insert, and ck tibil insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.
  • Acción
    Ortho Development notified all affected consignees/distributors of the recall via email on July 11, 2014 which included a list of the affected product (part numbers, lot numbers and quantities) under their control. An RMA number and return shipping label were also included with the email. Emails were followed up with phone calls to verify receipt of the notification.

Device

Device Recall Tibila Insert UC
  • Modelo / Serial
    UC Tibial Insert Sz 3 10mm,Part 163-3310,Lot A136109,UC Tibial Insert Sz 4 8mm,Part 163-3408,Lot A135948,UC Tibial Insert Sz 4 14mm,Part 163-3414,Lot A136110,UC Tibial Insert Sz 6 7mm,Part 163-3607,Lot A136113,UC Tibial Insert Sz 6 7mm,Part 163-3607,Lot A136746,
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.
  • Descripción del producto
    Tibila Insert UC, Balanced Knee System, REF163-3YYY || Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
  • Manufacturer
    Ortho Development Corporation

Manufacturer

Ortho Development Corporation
  • Dirección del fabricante
    Ortho Development Corporation, 12187 Business Park Dr, Draper UT 84020-8663
  • Empresa matriz del fabricante (2017)
    Ortho Development Corporation
  • Source
    USFDA