Events

Retiro De Equipo (Recall) de Device Recall EXACTECH

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 Exactech, 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
    77004
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2668-2017
  • Fecha de inicio del evento
    2017-05-25
  • 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=154811
  • 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
    Rongeur - Product Code HTX
  • Causa
    Instructions for use (ifu) is updated to clarify the proper technique and instrumentation to ream the glenoid, i.E., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
  • Acción
    On May 22, 2017 Exactech sent a Notification to all their Direct Accounts an Distributors telling them that a new updated technical techniques LIT # 718-01-30 Rev J is now available in their website (www.exac.com) or can be requested by contacting the Customer Service Representative at 800-392-2832, fax 352-378-2617 or via e-mail at Kaya@exac.com. This updated the technical techniques for implantation for Equinoxe Platform Shoulder System to clarify the proper technique for use of the Pilot Tip Reamers, i.e., to include caution statement that the surgeon should avoid applying a bending force to the pilot tip reamer and should avoid using the reamer to retract the humeral head, as this may result in instrument breakage. The notification also request to forward and informed this notice to all the accounts that have received this product and to complete and return the attached Field Advisory Notice Respond Form within 5 days of receipt. For more information please contact: Kaya Davis, Inventory Representative at kaya@exac.com or by phone at (352) 377-1140

Device

Device Recall EXACTECH
  • Modelo / Serial
    All Lots
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, Hawaii and Puerto Rico Australia, Austria, Brazil, Canada, China, France, Germany, Greece, India, Italy, Korea, Luxembourg, Singapore, South Africa, Spain, Sweden, Switzerland, The Netherlands and United Kingdom
  • Descripción del producto
    EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-45-38, Catalog #: 321-45-42 and Catalog #: 321-45-46
  • Manufacturer
    Exactech, Inc.

Manufacturer

Exactech, Inc.
  • Dirección del fabricante
    Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
  • Empresa matriz del fabricante (2017)
    Exactech Inc
  • Source
    USFDA