Devices

CUTTING BUR

Manufacturer

BIOMET MICROFIXATION ALSO TRADING AS WALTER LORENZ SURGICAL INC.
  • Manufacturer Address
    JACKSONVILLE
  • 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
    HC

68 devices with a similar name

Learn more about the data here

Device Recall Anspach Carbide Cutting Burrs
  • Model / Serial
    All Lot numbers distributed within the 5 years expiration date (12/13 thru 10/18)
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (Nationwide) including state of Hawaii and Internationally to: Australia, Poland, Canada, South Africa, Israel, and Switzerland.
  • Product Description
    Anspach Carbide Cutting Burrs & Drums: || 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-C || Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
  • Manufacturer
    The Anspach Effort, Inc.
Device Recall AnspacSingle use Sterile bone cutting burs
  • Model / Serial
    Lot #'s: D293037349, D323038110 and D363039140
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CA, CO, IN, KY, MD and TX and Internationally to Japan, Taiwan, United Kingdom, Sweden, and Germany.
  • Product Description
    AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only || Single use Sterile bone cutting burs.
  • Manufacturer
    The Anspach Effort, Inc.
Anspach MCA Cutting Burr, DFU Rx Only
  • Model / Serial
    ALL LOTS for product code 18-0001
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Great Britain, Australia, Switzerland, Sweden, France, Japan, Spain, Italy, Canada, and Netherlands.
  • Product Description
    Anspach MCA Cutting Burr, DFU Rx Only || Designed for cutting and shaping delicate bone, primarily in otology procedures
  • Manufacturer
    The Anspach Effort, Inc.
Anspach Single Use Sterile Bone Cutting Burrs
Cutting Burrs / Irrigation Clips
  • Model / Serial
    Cutting Burrs and Irrigation Clips | See attachment
  • Product Description
    MD: Cranial bur, single-use
  • Manufacturer
    The Anspach Effort
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