Device Recall Zodiac Pedicle Screw System

  • Modèle / numéro de série
    Lot # 634745
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including TN, WI, and FL.
  • Description du dispositif
    TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. || Subsequent Product Codes: MNH, MNI. || The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral portion of the spine. It intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac Polyaxial Pedicle Screw System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Alphatec Spine, Inc., 5818 El Camino Real, Carlsbad CA 92008-8816
  • Société-mère du fabricant (2017)
  • Source
    USFDA