Device Recall Cylindrical Reamer

  • Model / Serial
    18100
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain.
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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 devices with a similar name

Learn more about the data here

  • Model / Serial
    060890, 077020 and 605240.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain.
  • Product Description
    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
  • Model / Serial
    180900 and 957590
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain.
  • Product Description
    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
  • Model / Serial
    047610 and 833210
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain.
  • Product Description
    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
  • Model / Serial
    605070
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain.
  • Product Description
    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
  • Model / Serial
    015370 and 039230.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain.
  • Product Description
    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
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