Events

Retiro De Equipo (Recall) de 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
    26919
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1211-03
  • Fecha de inicio del evento
    2003-08-01
  • Fecha de publicación del evento
    2003-09-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28747
  • 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
    Orthopedic Manual Surgical Instrument - Product Code LXH
  • Causa
    Misalignment of the fixation holes between the tibial augment block trials and the corresponding tibial tray trials and trapezoid tray trials. the misalignment of the pin fixation holes only creates an issue when augmentation is used.
  • Acción
    A recall letter dated July 31, 2003, requesting return of certain Tibial Augmentation Block Trials and an advisory (Field Advisory K-078) on the use of certain Tibial Tray Trials and Trapezoid Tibial Tray Trials. The recall letter gives the address to return product as: Exactech, 2243 NW 66th Court, Gainesville, FL. Consignees were told to immediately cease distribution or use of the recalled products and to return them. Also the letter asks them to extend the recall information to their user accounts and to read and comply with the instructions provided in the attached 'Field Advisory K-078'. This advisory instructs the dealers and users on the use of the devices to avoid problems.

Device

Exactech
  • Modelo / Serial
    Tibial Augment block Trial, Catalog # 205-60-05, Lot #''s 4786-001 and 6509-001 Tibial Augment Block Trial, Catalog # 205-60-08 Lot #''s 4786-002 and 6509-002 Tibial Tray Trial, Catalog # 201-70-81, Lot #''s 4580-002, 6449-002 & 09861014 Trapezoid Tray Trial, Catalog # 205-70-81, Lot #''s 4603-002 & 6449-013
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide. Also the products were distributed to three intenational accounts in Spain, Japan and China.
  • Descripción del producto
    Exactech Tibial Augmentation Block Trial Size 0, Exactech Tibial Tray Trial size 1 Delta and Exactech Trapezoid Tray Trial size 1 Delta.
  • Manufacturer
    Exactech, Inc.

Manufacturer

Exactech, Inc.
  • Dirección del fabricante
    Exactech, Inc., 2320 N.W. 66th Court, Gainesville FL 32653
  • Source
    USFDA