Device Recall Tibila Insert CK

  • Model / Serial
    CK Tibial Insert Sz 6 12mm Part 563-1612, Lot A135666
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Ortho Development Corporation, 12187 Business Park Dr, Draper UT 84020-8663
  • Manufacturer Parent Company (2017)
  • Source
    USFDA