FDAFDA · Alimentos y medicamentos·N.º oficial Z-0810-2018
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.
Publicado el 7 de marzo de 2018 · Inicio del retiro: 8 de septiembre 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
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Howmedica Osteonics Corp.
- Distribuidor
- Nationally
- Lote
- Model# 800804 Lot numbers 160010 and 170003
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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