Devices

Device Recall ZMS Intramedullary Fixation Smooth Guide Wire

  • Model / Serial
    Lot Numbers:  63662549 63668704 63696974 63709171 63721377 63731176 63764550 63771164 63781920 63803595 63812302 63817719 63826242
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
  • Product Description
    ZMS Intramedullary Fixation Smooth Guide Wire || 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-037-00
  • 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

2 devices with a similar name

Learn more about the data here

Device Recall ZMS Intramedullary Fixation Smooth Guide Wire
  • Model / Serial
    Lot Numbers:  63715690 63780127 63787482
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
  • Product Description
    ZMS Intramedullary Fixation Smooth Guide Wire || 2.4 mm Diameter, 100 cm Length; Item Number: 47-2237-033-00
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall ZMS Intramedullary Fixation Smooth Guide Wire
  • Model / Serial
    Lot Numbers:  63645655 63650115 63650116 63655995 63655996 63655997 63655998
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
  • Product Description
    ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip || 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-038-00
  • Manufacturer
    Zimmer Biomet, Inc.