Device Recall Innovasis Excella II Standard

  • Modelo / Serial
    E2S47525 Lot 1301 and E2S47535 Lot 1301
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.
  • Descripción del producto
    Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Innovasis, Inc, 614 E 3900 S, Salt Lake City UT 84107-1902
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA