Manufacturers

Abbott Spine

14 devices in the database

Device Recall TraXis Vue Implant System
  • Model / Serial
    Lot #2010292
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide. Implants distributed to Sales Representatives in AZ, CA, FL, GA, KY, IL, MA, NY, OK, PA, TX, UT, VA and WI.
  • Product Description
    TraXis Vue Spinal Implant System, Part #2601-090921
Device Recall SCAcuFix Anterior Cervical Plating Systems
  • Model / Serial
    SC-AcuFix Core Instruments Surgical Techniques: Doc #499-0062-MKC, rev A.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide. Surgical Techniques for the SC-AcuFix Anterior Cervical Plating Systems distributed to Sales Agencies and surgeons throughout the U.S.
  • Product Description
    SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine, SlimLine Hybrid, Corpectomy, ThinLine and Ant-Cer Anterior Cervical Plating Systems.
Device Recall SCAcuFix Anterior Cervical Plating Systems
  • Model / Serial
    SC-AcuFix SlimLine Surgical Techniques: Doc #499-0005-MKC, rev D.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide. Surgical Techniques for the SC-AcuFix Anterior Cervical Plating Systems distributed to Sales Agencies and surgeons throughout the U.S.
  • Product Description
    SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine and SlimLine Hybrid Anterior Cervical Plating Systems.
Device Recall SCAcuFix Anterior Cervical Plating Systems
  • Model / Serial
    SC-AcuFix Corpectomy Surgical Techniques: Doc #499-0057-MKC, rev A.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide. Surgical Techniques for the SC-AcuFix Anterior Cervical Plating Systems distributed to Sales Agencies and surgeons throughout the U.S.
  • Product Description
    SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix Corpectomy Anterior Cervical Plating Systems.
Device Recall SCAcuFix Anterior Cervical Plating Systems
  • Model / Serial
    SC-AcuFix ThinLine Surgical Techniques: Doc #499-0035-MKC, rev B.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide. Surgical Techniques for the SC-AcuFix Anterior Cervical Plating Systems distributed to Sales Agencies and surgeons throughout the U.S.
  • Product Description
    SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix ThinLine Anterior Cervical Plating Systems.
9 more

3 manufacturers with a similar name

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Abbott Spine
  • Source
    BAM
Abbott Spine Inc.
  • 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
    BAM
Abbott Spine
  • 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
    HPRA