Device Recall 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm

  • Modèle / numéro de série
    Lot 009SV
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA including OK, KY, FL, LA, OH, CO, MO, MN and Internationally to Ireland, Saudi Arabia, Italy, Turkey, South Africa, and Germany.
  • Description du dispositif
    3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm || Part No. 00-0903-2620 || OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone Screw designed for use with this system.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    OrthoPediatrics Corp, 2850 Frontier Dr, Warsaw IN 46582-7001
  • Société-mère du fabricant (2017)
  • Source
    USFDA