Events

Retiro De Equipo (Recall) de Suture Washer

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
    75050
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2918-2016
  • Fecha de inicio del evento
    2016-08-12
  • Estado del evento
    Open, Classified
  • 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=149192
  • 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
    Washer, bolt nut - Product Code HTN
  • Causa
    The device was assembled incorrectly. suture and washer were not assembled; components were placed loose in the package.
  • Acción
    Consignees were notified 8/12/2016 of the potentially affected devices; Product/Batch Numbers: AR-7000-818T Batch #10028617. For Healthcare Professionals: immediately discontinue use of all affected products with stated numbers in their possession. Call (855) 552-5056 or email returns@arthrex.com with the product number, lot, and quantities so they may ship replacement products and expedite return of recalled product. To please complete the "Recall Acknowledgement of Receipt: postal card and return to Arthrex, Inc. Distributing Agencies: Immediately identify and hold all stated products in your inventory. Call 888-519-7255 ext. 72067 or e-mail AIM@arthrex.com Attn: Christi Zimmer. Have product number, lot number and quantities you may have so replacement product may be shipped and expedite the return of the recalled product. Please complete the "Recall Acknowledgement of Receipt" postal card and return to Arthrex. Inc. Any questions about the return of products to call 866-267-9138 and ask for Ellen Barry. Also by email to complaints@arthrez.com.

Device

Suture Washer
  • Modelo / Serial
    Unique Device Identifier (UDI): 00888867118607;  Catalog # AR-7000-18T; Batch #10028617.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    OR, NY, MN, KY, CA, ID, CO, MA, and FL. Thailand.
  • Descripción del producto
    Arthrex Suture Washer
  • 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