Zimmer Segmental System, ZSS Distal Femur.

  • Modelo / Serial
    a. Item No. 00585001201 (Lot Expiration Date Before 07/31/2026);  b. Item No. 00585001202 (Lot Expiration Date Before 07/31/2026);  c. Item No. 00585001301 (Lot Expiration Date Before 08/31/2026);  d. Item No. 00585001302 (Lot Expiration Date Before 07/31/2026)
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico; and to countries of: Austria, Australia, Bahamas, Brazil, Canada, China, Dominican Republic, England, France, Germany, Israel, Japan, South Korea, Lebanon, Malaysia, Mexico, Netherlands, Panama, Singapore, Spain, Switzerland, and Thailand.
  • Descripción del producto
    Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: || a. Size B-LT (Item No. 00585001201); || b. Size B-RT (Item No. 00585001202); || c. Size C-LT (Item No. 00585001301); || d. Size C-RT (Item No. 00585001302) || Components of the system are intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia, and/or total knee in cases that require extensive resection and restoration.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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