Device Recall Apollo Knee Tibial Baseplate/Knee Tibial Insert

  • Model / Serial
    Item Number 681100019 681100022 681101009 681101011 681101019 681102013 681102019 681103009 681103013
  • 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
    Apollo Knee Tibial Baseplate/Knee Tibial Insert: || CONG TIB INS SZ0/19MM APO || CONG TIB INS SZ0/22MM APO || CONG TIB INS SZ1/9MM APOL || CONG TIB INS SZ1/11MM APO || CONG TIB INS SZ1/19MM APO || CONG TIB INS SZ2/13MM APO || CONG TIB INS SZ2/19MM APO || CONG TIB INS SZ3/9MM APOL || CONG TIB INS SZ3/13MM APO
  • 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