Device Recall Polyaxial Pedicle Screw

  • Modèle / numéro de série
    Catalog/Part No.: E2S8530, E2S8535, E2S8540, E2S8545, E2S8550, E2S8555, E2S8560 with Lot Number: 1101 and Catalog/Part No.: E28540, E28545 with Lot Number: 1201. Each of these parts is engraved with part number and lot number.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    United States
  • Description du dispositif
    Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:
  • 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