Devices

Device Recall Disposable Coring Trephine

  • Model / Serial
    648180 and 648200.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
  • Product Description
    8 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900728, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. || Usage: Bone Coring Device used in ACL and PCL procedures.
  • Manufacturer
    Biomet, Inc.
  • 1 Event

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • 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

4 devices with a similar name

Learn more about the data here

Device Recall Disposable Coring Trephine
  • Model / Serial
    Lot 804350, exp. 11/30/2014
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
  • Product Description
    7 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900727, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. || Usage: Bone Coring Device used in ACL and PCL procedures.
  • Manufacturer
    Biomet, Inc.
Device Recall Disposable Coring Trephine
  • Model / Serial
    821010 and 821020.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
  • Product Description
    9 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900729, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. || Usage: Bone Coring Device used in ACL and PCL procedures.
  • Manufacturer
    Biomet, Inc.
Device Recall Disposable Coring Trephine
  • Model / Serial
    92620
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
  • Product Description
    10 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900730, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. || Usage: Bone Coring Device used in ACL and PCL procedures.
  • Manufacturer
    Biomet, Inc.
Device Recall Disposable Coring Trephine
  • Model / Serial
    780470
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
  • Product Description
    8 MM DISPOSABLE CORING TREPHINE STAGGERED TEETH WITH PROTECTION SLEEVE, REF 900788, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. || Usage: Bone Coring Device used in ACL and PCL procedures.
  • Manufacturer
    Biomet, Inc.