Events

Retiro De Equipo (Recall) de Device Recall JariTrak Table Clamp

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 J. Jamner Surgical Instruments, 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
    37369
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0596-2007
  • Fecha de inicio del evento
    2006-11-14
  • Fecha de publicación del evento
    2007-03-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-01-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50440
  • 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
    table clamp - Product Code KDC
  • Causa
    The jaritrak table clamp may not securely fasten to the bed rail of the or table during set up of the retractor system. in the event that the clamp is not securely fastened to the bed rail, the system may move during surgery. the firm received several complaints from hospitals.
  • Acción
    On 11/14/06, an "URGENT-PRODUCT NOTIFICATION" letter (dated 11/14/06) and accompanying Fax Back Form were sent via Certified Mail Return Receipt Requested, to each customer that purchased or was supplied with the 206-160 Table Clamp. The letter instructs each surgical instrument coordinator (user) to review the inventory of 206-160 JariTrak" Table Clamps at the facility. The letter also provides instructions for the proper installation of the clamp to the bed rail. The customer is also asked to complete the Fax Back Form and fax it to back to Customer Service. J. Jamner Surgical Instruments, Inc. (J. Jamner) will replace any Table Clamps at the request of the customer. J. Jamner will account for all Fax Back replies and product returns. A second notification letter will be sent to any non-responding customers. Table Clamps returned from customers and from J. Jamner's inventory will be returned to the manufacturer, Koros USA Inc. or be destroyed by J. Jamner.

Device

Device Recall JariTrak Table Clamp
  • Modelo / Serial
    Manufacturer lot numbers 55L and 125L
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    JariTrak Table Clamp, 1 inch diameter, vertical post, Catalog Number 206-160. The JariTrak Table Clamp with vertical post (206-160) is part of the Table Mounted Hardware that is used with the JariTrak™ Retractor System. The JariTrak™ self-retaining retractor system consists of the Table Clamp with Vertical Post, Flexible or Horizontal Bar with Universal Joint, Oval or Segment Rings, Tilting Blade Clamps and various blades. The product is supplied non-sterile and may be packaged individually or as part of the JariTrak™ retractor set.
  • Manufacturer
    J. Jamner Surgical Instruments, Inc.

Manufacturer

J. Jamner Surgical Instruments, Inc.
  • Dirección del fabricante
    J. Jamner Surgical Instruments, Inc., 9 Skyline Dr, Hawthorne NY 10532-2100
  • Source
    USFDA