Device Recall Tibila Insert UC

  • Modelo / Serial
    UC Tibial Insert Sz 3 10mm,Part 163-3310,Lot A136109,UC Tibial Insert Sz 4 8mm,Part 163-3408,Lot A135948,UC Tibial Insert Sz 4 14mm,Part 163-3414,Lot A136110,UC Tibial Insert Sz 6 7mm,Part 163-3607,Lot A136113,UC Tibial Insert Sz 6 7mm,Part 163-3607,Lot A136746,
  • 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 UC, Balanced Knee System, REF163-3YYY || Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
  • 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