Devices

NexGen Offset Stem Extension

  • Model / Serial
    Item Number: 00-5988-020-14, Lot Number: 63463357, Description: NexGen Offset Stem Ext Size 14, UDI: (01)00889024221475(17)260930(10)63463357; Item Number: 00-5988-020-17, Lot Number: 63463367, Description: (01)00889024221505(17)260930(10)63463367, Manufactured Date: 9/19/2016, Expiration Date: 9/30/2026
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Distribution to the states of: WI, CA, PA, NJ, IN, VA, WA, MN and HI ., and to the countries of : Brazil, Canada, Australia, Netherlands, Germany, Iran and Nigeria. VA/DOD: None
  • Product Description
    NexGen Offset Stem Extension, sizes 14mm and 17mm || For use in total arthroplasty.
  • Manufacturer
    Zimmer Biomet, Inc.
  • 1 Event

Manufacturer

Zimmer Biomet, Inc.
  • Manufacturer Address
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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

One device with a similar name

Learn more about the data here

NexGen Offset Stem Extension size 14 and size 17
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Non-active implants - bone surgery
  • Manufacturer
    Zimmer Inc.