Device Recall Cylindrical Reamer

  • Modèle / numéro de série
    060890, 077020 and 605240.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain.
  • Description du dispositif
    Cylindrical Bullet Nose Reamer 12.5 mm x 250 mm, REF 475813, Biomet Orthopedics 66 East Bell Drive Warsaw IN. || The product is used to prepare the femoral canal for stem implantation.
  • 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

20 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    180900 and 957590
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain.
  • Description du dispositif
    Cylindrical Bullet Nose Reamer 13.0 mm x 250 mm, REF 475814, Biomet Orthopedics 66 East Bell Drive Warsaw IN. || The product is used to prepare the femoral canal for stem implantation.
  • Manufacturer
  • Modèle / numéro de série
    047610 and 833210
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain.
  • Description du dispositif
    Cylindrical Bullet Nose Reamer 13.5 mm x 250 mm, REF 475815, Biomet Orthopedics 66 East Bell Drive Warsaw IN. || The product is used to prepare the femoral canal for stem implantation.
  • Manufacturer
  • Modèle / numéro de série
    18100
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain.
  • Description du dispositif
    Cylindrical Bullet Nose Reamer 14.0 mm x 250 mm, REF 475816, Biomet Orthopedics 66 East Bell Drive Warsaw IN. || The product is used to prepare the femoral canal for stem implantation.
  • Manufacturer
  • Modèle / numéro de série
    605070
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain.
  • Description du dispositif
    Cylindrical Bullet Nose Reamer 7.0 mm x 250 mm, REF 475802, Biomet Orthopedics 66 East Bell Drive Warsaw IN. || The product is used to prepare the femoral canal for stem implantation.
  • Manufacturer
  • Modèle / numéro de série
    015370 and 039230.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain.
  • Description du dispositif
    Cylindrical Bullet Nose Reamer 7.5 mm x 250 mm, REF 475803, Biomet Orthopedics 66 East Bell Drive Warsaw IN. || The product is used to prepare the femoral canal for stem implantation.
  • Manufacturer
15 en plus