Device Recall Zimmer Universal Locking System

  • Modèle / numéro de série
    LOT: 63297474
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
  • Description du dispositif
    Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • 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

Un dispositif médical avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Part 00-4936-011-13, Lot 62968956 3.5MM ULS RECON PLATE 11H Part 00-4936-008-07, Lot 62968974 3.5MM ULS DUAL COMP PLT 8
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- USA, including the states of MN, NY, MS, AL, OH, KY, ME, and NM; and, the countries of Taiwan, Korea, Singapore, El Salvador, Uruguay, Czech Republic, France, Italy, Poland, United Kingdom, South Africa, and Slovakia.
  • Description du dispositif
    Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate || Straight 11 Holes 144mm Length || Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate || 8 Holes 105mm Length. || Indicated for temporary internal fixation and stabilization of osteotomies and fractures.
  • Manufacturer