Vanguard Complete Knee System

  • Model / Serial
    Item #183066/Lot 132900; UDI-(01) 0088030427068 (17) 270816 (10) 132900
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to states of: FL, WI, MD, MO, and MI.
  • Product Description
    Vanguard CR Porous Femoral 62.5mm (Left Femur) || For use in total knee arthroplasty
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA

4 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lots 198810 and 210320
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed to accounts in CA, CT, GA, IA, IN, LA, MA, MD, MN, MS, NJ, OH, PA, TN, TX, UT, VA, WI. Foreign distribution to Taiwan, Japan, and the Netherlands.
  • Product Description
    Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 || Product Usage: The product is intended for use in knee joint replacement arthroplasties.
  • Manufacturer
  • Model / Serial
    Item Number 184108 Lot Number 183410 Exp. 8/27/2025
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide in the states of NJ, MI, FL and the countries of Sweden and Canada.
  • Product Description
    Vanguard Distal Femoral Augment 75 X 5 RL/LM || Product Usage: || Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.  Correction of varus, valgus, or posttraumatic deformity.  Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.  The device is a single use implant intended for implantation with bone cement.
  • Manufacturer
  • Model / Serial
    Lot Number: 388680, Exp. Date 5/19/2022
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide in the states of CA, GA, KS, LA, MA, MI, MN, OH, TX, VA, WA, WI, and the countries of Netherlands
  • Product Description
    Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 || Product Usage: || For use in total knee arthroplasty
  • Manufacturer
  • Model / Serial
    Lot Number: 473290, Exp. Date 5/19/2022
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide in the states of CA, GA, KS, LA, MA, MI, MN, OH, TX, VA, WA, WI, and the countries of Netherlands
  • Product Description
    Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 || Product Usage: || For use in total knee arthroplasty
  • Manufacturer