Device Recall Apex Knee System

  • Modèle / numéro de série
    Product Code KC-2206L, Lot # 26519
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US Distribution and to the country Spain.
  • Description du dispositif
    Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L || The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    OMNIlife science Inc., 480 Paramount Dr, Raynham MA 02767-1085
  • Société-mère du fabricant (2017)
  • Source
    USFDA