Device Recall Tibila Insert CK

  • Modelo / Serial
    CK Tibial Insert Sz 6 12mm Part 563-1612, Lot A135666
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.
  • Descripción del producto
    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

Fabricante

  • Dirección del fabricante
    Ortho Development Corporation, 12187 Business Park Dr, Draper UT 84020-8663
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA