Events

Retiro De Equipo (Recall) de iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL

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 Arthrex, 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
    78297
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0095-2018
  • Fecha de inicio del evento
    2017-10-03
  • Estado del evento
    Completed
  • 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=159082
  • 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, femorotibial, non-constrained, cemented, metal/polymer - Product Code HSX
  • Causa
    Arthrex part number ar-501-uflc, size 3, batch 10123297, has the incorrect part number ar-501 ¿ufra, size 1 printed on the patient label inside the box.
  • Acción
    Arthrex sent an Urgent Medical Device Voluntary Recall letter on October 3, 2017. The letter requested the following: "Immediately discontinue use of these devices. In order to receive credit for the returned devices, please follow the steps below: 1) Review this notification and ensure affected personnel are aware of the contents. 2) Immediately identify and return all the indicated product/batch numbers you have in inventory. Call Arthrex Field Logistics Service at 1-866¿612-7899 for a returned goods authorization (RGA) and product return instructions. Email: FLS@Arthrex.com." Customers with questions were instructed to call Product Surveillance at 866-267-9138 or by email to commplaints@arthrex.com.

Device

iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL
  • Modelo / Serial
    batch 10123297
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US including SD, NV, NC, CA, MD, AZ, CA, LA, FL, PA, TX, NY, GA, and Internationally to GERMANY, POLAND
  • Descripción del producto
    iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL || Indicated for use in uni-compartmental knee arthroplasty as a result of: 1. Moderately disabling joint disease of the knee resulting from painful osteoarthritis or posttraumatic arthritis. 2. Correction of functional deformity. 3. Revision of previous unsuccessful uni-compartmental knee replacement or other procedure. 4. As an alternative to tibial osteotomy in patients with uni-compartmental osteoarthritis.
  • Manufacturer
    Arthrex, Inc.

Manufacturer

Arthrex, Inc.
  • Dirección del fabricante
    Arthrex, Inc., 1370 Creekside Blvd, Naples FL 34108-1945
  • Empresa matriz del fabricante (2017)
    Arthrex, Inc.
  • Source
    USFDA