Device Recall ACL Reconstruction System Installation tools

  • Modèle / numéro de série
    Part 01-1008-0040/0047 Lot 132762, F132763, F132764, F132765, F132766, F132768, F132769, F132770
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including the states of CA, KY, OH, RI, and TN.
  • Description du dispositif
    OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. || Used with ACL reconstruction system associated surgery.
  • Manufacturer
  • 1 Event

Fabricant

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