Device Recall Zimmer

  • Modelo / Serial
    Item No. 00-5852-052-10; Lot 62866438
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution to the state of TX
  • Descripción del producto
    Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem || Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Zimmer, 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

263 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lot P020077.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    The product was shipped to Hawaii, New York, South Carolina, and South Dakota in the United States.
  • Descripción del producto
    Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Zimmer Spine Trinica Anterior Cervical Plating Instrument sets (catalog numbers 07.00215.001 and 07.00546.001). Only the Trinica Bone Tap Instruments are being recalled from the sets.
  • Manufacturer
  • Modelo / Serial
    Lots 60244776, 60254445, 60270467, 60278638, 60298344, 60317739, 60330363 and 60342788.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • Descripción del producto
    Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Left, 45 degrees, non-sterile; Part number 00-7712-035-01.
  • Manufacturer
  • Modelo / Serial
    Lots 60244777, 60254446, 60259343, 60280558, 60295662, 60298480, 60307612, 60333170 and 60336853.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • Descripción del producto
    Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; Part number 00-7712-035-02.
  • Manufacturer
  • Modelo / Serial
    Lots 08686700 and 08686500.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • Descripción del producto
    Zimmer M/L Taper Rasp Handle, Left, 45 degrees, non-sterile; Part number 83-7712-035-01. Recall Z-0671-06 extended to include this product.
  • Manufacturer
  • Modelo / Serial
    Lots 08686600 and 08686800.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • Descripción del producto
    Zimmer M/L Taper Rasp Handle, Right, 45 degrees, non-sterile; Part number 83-7712-035-02. Recall Z-0671-06 extended to include this product.
  • Manufacturer
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