FDAFDA · Alimentos y medicamentos·N.º oficial Z-1737-2013
KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into place with a set screw or locking cap. The rod may be placed along several pedicle screws. Component rods are used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients.
Publicado el 24 de julio de 2013 · Inicio del retiro: 30 de diciembre de 2011
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
One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles.
Qué hacer
Voluntary: Firm initiated · Telephone
Detalles del retiro
- Fabricante
- SpineFrontier, Inc.
- Distribuidor
- USA Nationwide Distribution including the state of TX
- Lote
- Lot Number: 002876-007R
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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