Device Recall Intramedullary Bone Saw

  • Modèle / numéro de série
    Lot 239430, 239450
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) to states of: NY, TX, MI, and M; to countries of: Australia and The Netherlands.
  • Description du dispositif
    Part 475625, Intramedullary Bone Saw, Cam Assembly || Size 13 mm, || The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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

2 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Lot 239470, 457450
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) to states of: NY, TX, MI, and M; to countries of: Australia and The Netherlands.
  • Description du dispositif
    Part 475630, Intramedullary Bone Saw, Cam Assembly || Size 14 mm, || The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.
  • Manufacturer
  • Modèle / numéro de série
    Lot 669420
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) to states of: NY, TX, MI, and M; to countries of: Australia and The Netherlands.
  • Description du dispositif
    Part 475620 Intramedullary Bone Saw CAM Assembly || Size 12mm, || A unique and exclusive clinical instrument used to correct leg length, or rotational discrepancies in the femur.
  • Manufacturer