Device Recall SC2316, Distal Femoral Augment with Screw

  • Modèle / numéro de série
    Part number SC2316-3-5 with lot number 22389-111609. Part number SC2316-4-5 with lot number 22587-111609. Part number SC2316-5-5 with lot number 23214-111609.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including TX, VA, OK, and PA
  • Description du dispositif
    SC2316, Distal Femoral Augment with Screw || Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Stelkast Co, 200 Hidden Valley Rd, Mcmurray PA 15317-2659
  • Société-mère du fabricant (2017)
  • Source
    USFDA