Device Recall DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS

  • Modèle / numéro de série
    Lot Code: 17800601.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution (AL, OH, MN, NM, and CA).
  • Description du dispositif
    Duracon Total Knee, A-P Lipped Tibial Insert; 11MM || Sterile; Howmedica Osteonics Corp. || Stryker, Ireland. Product No. 6642-1-611. || The device is used to replace bearing surface if the proximal tibia in order to relieve pain, instability and/or restriction of motion due to degenerative joint disease, failed previous prosthesis or trauma. The tibial inserts are designed to accommodate the posterior cruciate ligament if it is present. These components are intended for implantation with bone cement only.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430
  • Société-mère du fabricant (2017)
  • Source
    USFDA