FDAFDA · Alimentos y medicamentos·N.º oficial Z-0111-2015
Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).
Publicado el 29 de octubre de 2014 · Inicio del retiro: 30 de septiembre 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
Packaging of a device was compromised
Qué hacer
Voluntary: Firm initiated
Detalles del retiro
- Fabricante
- Signal Medical Corporation
- Distribuidor
- Worldwide Distribution - US (Nationwide) in the state of: MO and internationally to: Panama.
- Lote
- Catalog # 22-01-02106; Lot # 1110; Serial # L0259; Size 6R Catalog #22-01-02106; Lot # 2910; Serial # L0533; Size 6R Catalog # 22-01-02003, Serial #s L0280,L0283, L0284, L0285, L0287, L0288, L0615, Size 3 L Catalog # 22-01-02004, Serial # l0358, Size 4L Catalog # 22-01-02005, Serial # L0809; Size 5L Catalog #22-01-02006; Serial #s L0692, L0842, L0485, L0483, L0486, L0841, L0844, L0847, Size 6L Catalog # 22-01-02007, Serial #s L0721, L0786, L0787, L0770, L0772, L0775, Size 7L Catalog #22-01-02103, Serial #s L0265, L0272, Size 3R Catalog # 22-01-02104, Serial #s L0479, L0515, L0517, Size 4R Catalog # 22/01-02106, Serial # L0338, L0508, L0537, L0853, L0867, L0872, L0873, Size 6R Catalog #22-01-02107, Serial #s L0749, L0758, L0760, L0755, L0759, L0762, Size 7R
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.