Device Recall Rods Pedicle screw spinal system

  • Modèle / numéro de série
    Lot Number: 002876-007R
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    USA Nationwide Distribution including the state of TX
  • Description du dispositif
    KRD1 PedFuse Rods, Model: IM80100-13 Rev B || Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into place with a set screw or locking cap. The rod may be placed along several pedicle screws. Component rods are used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    SpineFrontier, Inc., 500 Cummings Ctr Ste 3500, Beverly MA 01915-6516
  • Société-mère du fabricant (2017)
  • Source
    USFDA