Device Recall Disposable Dowel Harvest Tube

  • Model / Serial
    705630
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
  • Product Description
    7 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900737, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. || Usage: Bone Coring Device used in ACL and PCL procedures.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582
  • 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

3 devices with a similar name

Learn more about the data here

  • Model / Serial
    019900, 019950 and 821060.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
  • Product Description
    10 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900740, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. || Usage: Bone Coring Device used in ACL and PCL procedures.
  • Manufacturer
  • Model / Serial
    648210 and 648220.,
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
  • Product Description
    8 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900738, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. || Usage: Bone Coring Device used in ACL and PCL procedures.
  • Manufacturer
  • Model / Serial
    705650 and 804380.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
  • Product Description
    9 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900739, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. || Usage: Bone Coring Device used in ACL and PCL procedures.
  • Manufacturer