Device Recall Innovasis Excella II Standard

  • Modèle / numéro de série
    E2S47525 Lot 1301 and E2S47535 Lot 1301
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Innovasis, Inc, 614 E 3900 S, Salt Lake City UT 84107-1902
  • Société-mère du fabricant (2017)
  • Source
    USFDA