Device Recall NEXGEN COMPLETE KNEE SOLUTION REPLACEMENT JAW FOR USE WITH FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTO

  • Modèle / numéro de série
    6154826, 61645115 and 61690174.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution: USA (nationwide)including states of: HI, CA, NY, MI, IN, GA, FL, WI, MN, NJ, IL, VA, TX, NC, PA, MS, WA, OR, OH, KS, TN, NH, AZ, NV, UT and AK and countries of : Australia, Canada, China, Germany, India, Japan, Singapore and Sweden.
  • Description du dispositif
    NEXGEN COMPLETE KNEE SOLUTION FEMORAL REPLACEMENT JAW FOR USE WITH FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR , NONSTERILE, REF 00-5901-026-40, Zimmer UK, Ltd., Zimmer Warsaw, IN. || Intended use: The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
  • Manufacturer
  • 1 Event

Fabricant

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