Devices

Device Recall NaturalKnee II Constrained Knee System

  • Modèle / numéro de série
    Item Number 672009100 672009101 672009103 672009200 672009203 672011101 672011103 672011200 672011201 672011203 672013100 672013101 672013103 672013200 672013203 672016101 672016103 672016200 672016203 672019100 672019101 672019200 672019201 672022101 672022103 672022200 672022201 672025100 672025200
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    Natural-Knee¿ II Constrained Knee System || NKII CCK TIB INS SZ00/0-L || NKII CCK TIB INS SZ1/2-LF || NKII CCK TIB INS SZ3-5 -L || NKII CCK TIB INS SZ00/0-R || NKII CCK TIB INS SZ3-5 -R || NKII CCK TIB INS SZ1/2-LF || NKII CCK TIB INS SZ3-5 -L || NKII CCK TIB INS SZ00/0-R || NKII CCK TIB INS SZ1/2-RT || NKII CCK TIB INS SZ3-5 -R || NKII CCK TIB INS SZ00/0-L || NKII CCK TIB INS SZ1/2-LF || NKII CCK TIB INS SZ3-5 -L || NKII CCK TIB INS SZ00/0-R || NKII CCK TIB INS SZ3-5 -R || NKII CCK TIB INS SZ1/2-LF || NKII CCK TIB INS SZ3-5 -L || NKII CCK TIB INS SZ00/0-R || NKII CCK TIB INS SZ3-5 -R || NKII CCK TIB INS SZ00/0-L || NKII CCK TIB INS SZ1/2-LF || NKII CCK TIB INS SZ00/0-R || NKII CCK TIB INS SZ1/2-RT || NKII CCK TIB INS SZ1/2-LF || NKII CCK TIB INS SZ3-5 -L || NKII CCK TIB INS SZ00/0-R || NKII CCK TIB INS SZ1/2-RT || NKII CCK TIB INS SZ00/0-L || NKII CCK TIB INS SZ00/0-R
  • Manufacturer
    Zimmer, Inc.
  • 1 Event

Fabricant

Zimmer, Inc.
  • Adresse du fabricant
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “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