Device Recall Tibila Insert CK

  • Modèle / numéro de série
    CK Tibial Insert Sz 6 12mm Part 563-1612, Lot A135666
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.
  • Description du dispositif
    Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY || Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the femoral component where additional joint constraint is needed
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Ortho Development Corporation, 12187 Business Park Dr, Draper UT 84020-8663
  • Société-mère du fabricant (2017)
  • Source
    USFDA