Events

Retiro De Equipo (Recall) de ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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 Howmedica Osteonics Corp..

¿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
    79147
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0810-2018
  • Fecha de inicio del evento
    2017-09-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-07-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161444
  • 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
    When the lever of the insertion handle is in the "locked" position, the implant may be able to pivot rather than maintaining a rigid connection.
  • Acción
    A recall letter, dated August 25, 2017, titled "Product Recall Re: AccuLIFTL Insertion Handle" instructing customers to meet with the Stryker Representative issuing the letter, complete the requested form and return any affected product to this representative. Questions or concerns can be directed to Customer Service at 201-749-8699

Device

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  • Modelo / Serial
    Model# 800804 Lot numbers 160010 and 170003
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationally
  • Descripción del producto
    AccuLIF TL Insertion Handle || The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a surgeon to insert the implant into the disc space with a fixed engagement between the two components to permit a controlled positioning of the implant in the anterior portion of the intervertebral space, and then through activation of the rotational pivot between the Handle and implant for final placement of the crescent-shaped cage across the anterior portion of the disc space. The AccuLIF TL Cages are indicated for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DOD) at one level or two contiguous levels from L2 to S1.
  • Manufacturer
    Howmedica Osteonics Corp.

Manufacturer

Howmedica Osteonics Corp.
  • Dirección del fabricante
    Howmedica Osteonics Corp., 2 Pearl Ct, Allendale NJ 07401-1611
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA