Devices

Device Recall Patella

  • Model / Serial
    Patella 38mm Part 164-0038, Lot A135844
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.
  • Product Description
    Patella 38mm, REF164-0038 || Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component
  • Manufacturer
    Ortho Development Corporation
  • 1 Event

Manufacturer

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

One device with a similar name

Learn more about the data here

Device Recall Patella Trial
  • Model / Serial
    Part Number 802-01-019  Lot 53944551
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    United States (FL and ID).
  • Product Description
    Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551
  • Manufacturer
    Encore Medical, Lp