FDAFDA · Alimentos y medicamentos·N.º oficial Z-1086-2014
Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It is used for implant insertion in to the disc space. The AVS navigator Peek Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal fixation. These hollow implants are offered in a variety of lengths, heights and lordotic angles designed to adapt to different patient anatomies. They have serrations on the superior and inferior surfaces designed for multidirectional fixation and ergonomically shaped anterior edges and flat posterior edges.
Publicado el 5 de marzo de 2014 · Inicio del retiro: 18 de diciembre de 2013
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
Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Stryker Spine
- Distribuidor
- US Nationwide Distribution
- Lote
- D109140 Catalog # IS3009AVS Lot Serial # 3664, 3759, 3843, 3913, 4079, 4195 and 4242
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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