Device Recall Knee replacement system

  • Model / Serial
    Lot Number: 67224
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA including states of: AZ, CA, FL, MI, TX, and UT; and country of: Japan.
  • Product Description
    CR Tibial Insert, Size 5, 7mm, REF 163-2507, Sterile R, Ortho Development, Draper, Utah 84020. || The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base for the metal femoral portion of the system, and moderates the degree of flexion afforded by the procedure.
  • Manufacturer
  • 1 Event

Manufacturer

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

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Number: 670675.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA including states of: AZ, CA, FL, MI, TX, and UT; and country of: Japan.
  • Product Description
    UC Tibial Insert, Size 4, 13mm, REF 163-3413, Sterile R, Ortho Development, Draper, Utah 84020. || The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base for the metal femoral portion of the system, and moderates the degree of flexion afforded by the procedure.
  • Manufacturer
  • Model / Serial
    Lot Number: 670676
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA including states of: AZ, CA, FL, MI, TX, and UT; and country of: Japan.
  • Product Description
    UC Tibial Insert, Size 4, 12mm, REF 163-3412, Sterile R, Ortho Development, Draper, Utah 84020 || The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base for the metal femoral portion of the system, and moderates the degree of flexion afforded by the procedure.
  • Manufacturer