Events

Retiro De Equipo (Recall) de AgeeWristJack Fracture Reduction System

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 Hand Biomechanics Lab 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
    75255
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0136-2017
  • Fecha de inicio del evento
    2016-09-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149824
  • 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
    Component, traction, invasive - Product Code JEC
  • Causa
    A number of agee wristjack¿ fracture reduction systems have been manufactured with a molded beam slightly larger than optimal. this may result in the surgeon experiencing difficulty fine-tuning the length (red) and radial/ulnar alignment (blue) adjustments on the device.
  • Acción
    Hand Biomechanics Lab, Inc. sent a Voluntary Medical Device Recall letter to all affected customers beginning on September 14, 2016 and sent by phone/fax numbers - or e-mail. Letters request return of devices which have not yet been used. Customers with questions were instructed to contact Customer Service at (800) 522-5778. For questions regarding this recall call 916-923-5073.

Device

AgeeWristJack Fracture Reduction System
  • Modelo / Serial
    Lot number: HBL-115-165, serial numbers 47460959 and 47460980; Lot number: HBL-116-014 - all serial numbers; Lot number : HBL-116-040 - 15 systems shipped prior to recall
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Agee-WristJack¿ Fracture Reduction System; || Item number: CFD-147. || The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery || The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box. || Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures.
  • Manufacturer
    Hand Biomechanics Lab Inc

Manufacturer

Hand Biomechanics Lab Inc
  • Dirección del fabricante
    Hand Biomechanics Lab Inc, 77 Scripps Dr Ste 104, Sacramento CA 95825-6209
  • Empresa matriz del fabricante (2017)
    Hand Biomechanics Lab Inc
  • Source
    USFDA