Volver al buscador
FDAFDA · Alimentos y medicamentos·N.º oficial Z-1461-2017

L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Product Usage: The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). L-Varlock Lumbar implants are to be used with autogenous bone graft and implanted via an open posterior approach. L-Varlock Lumbar implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Publicado el 22 de marzo de 2017 · Inicio del retiro: 11 de enero de 2017

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Firm received a complaint of the tip holder breaking during use.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Kiscomedica S.A.
Distribuidor
Worldwide Distribution - US Nationwide in the states of MO and country of Switzerland.
Lote
Batch number: 15486
Clasificación de riesgo
Class II
Área (FDA)
device
País
France

¿Vendes productos como este?

Recalert vigila todo tu catálogo contra retiros como este, automáticamente.

Empezar gratis — sin tarjeta