Device Recall NaturalKnee II Unicompartmental Knee Prosthesis

  • Model / Serial
    Item Number 611001009 611001011 611001013 611002009 611002011 611002013 611003009 611003011 611003013
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.
  • Product Description
    Natural-Knee¿ II - Unicompartmental Knee Prosthesis: || CONG TIB INS SZ1/2 9MM UN || CONG TIB INS SZ1/2 11MM U || CONG TIB INS SZ1/2 13MM U || CONG TIB INS SZ3/4 9MM UN || CONG TIB INS SZ3/4 11MM U || CONG TIB INS SZ3/4 13MM U || CONG TIB INS SZ 5/6 9MM U || CONG TIB INS SZ5/6 11MM U || CONG TIB INS SZ5/6 13MM U
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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