FDAFDA · Alimentos y medicamentos·N.º oficial Z-1174-2014
Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. The wide selection of implants accommodates variable anatomy; precisely crafted instruments facilitate implant placement. Implant plate lateral slant of holes allows for angulation of screws. Elongated central holes provide flexibility in screw placement. Wide selection of length's accommodates individual case requirements.
Publicado el 19 de marzo de 2014 · Inicio del retiro: 27 de enero de 2014
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
Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine applications.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Synthes, Inc.
- Distribuidor
- USA Nationwide Distribution
- Lote
- All lots of Parts 489.401, 489.402, 489.412, 489.413, 489.414, 489.415, 489.418, 489.423, 489.424, and 489.425.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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