Devices

Comprehensive Shoulder System

  • Model / Serial
    Model Number: 113956, Modular Hybrid Glenoid Base Large, Item Number: 113956, Lot Number: 270260, UDI Number: (01) 00880304462618 (17) 211204 (10) 270260
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US including OH AZ ID PA AR MN IL CA MD CA MN NY Foreign: Canada
  • Product Description
    Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed product is then placed into a Tyvek/film pouch and that pouch is heat sealed. The fully pouched product is then labeled and placed into a carton with an IFU. The carton is then labeled and shrink wrapped. The labels also include a sterilization indication dot. || This system is intended for primary and revision total shoulder arthroplasty, as well as hemi-arthroplasty
  • Manufacturer
    Zimmer Biomet, Inc.
  • 1 Event

Manufacturer

Zimmer Biomet, Inc.
  • Manufacturer Address
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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

Containers of the Comprehensive Shoulder System Instrument. References 595608, 595260 and 595261.
  • Model / Serial
  • Manufacturer
    N/A
BIOMET Comprehensive Shoulder System
  • Model / Serial
    Part Numbers: 113644; Use-by 2025-03-18; Lot Numbers: 127340, 182030, 349650.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide in the states of AR, CA, IL, IN, PA, FL, KS, LA, WI, VA, MA, MD, NJ, UT, NC, TX, AL, MI, KY, OH, SD, MO, GA, NV, WA and the countries of: Europe, Canada, Japan, Chile, Korea, Mexico, New Zealand, Trinidad/Tobago, Thailand, Argentina, Australia, and China.
  • Product Description
    Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components.
  • Manufacturer
    Biomet, Inc.
COMPREHENSIVE SHOULDER SYSTEM NANO HUMERAL COMPONENT
  • Model / Serial
    Model Catalog: 115740 (Lot serial: ALL); Model Catalog: 115738 (Lot serial: ALL); Model Catalog: 115730 (Lot serial: ALL); Model Catalog: 115734 (Lot serial: ALL); Model Catalog: 115732 (Lot serial: ALL); Model Catalog: 115736 (Lot serial: ALL)
  • Product Description
    COMPREHENSIVE SHOULDER SYSTEM NANO HUMERAL COMPONENT
  • Manufacturer
    ZIMMER BIOMET CANADA INC.
COMPREHENSIVE SHOULDER SYSTEM NANO HUMERAL COMPONENT
  • Model / Serial
    Model Catalog: 115732 (Lot serial: ALL LOTS); Model Catalog: 115734 (Lot serial: ALL LOTS); Model Catalog: 115736 (Lot serial: ALL LOTS); Model Catalog: 115738 (Lot serial: ALL LOTS); Model Catalog: 115740 (Lot serial: ALL LOTS); Model Catalog: 115730 (Lot serial: ALL LOTS)
  • Product Description
    COMPREHENSIVE SHOULDER SYSTEM NANO HUMERAL COMPONENT
  • Manufacturer
    BIOMET CANADA INC.