Devices

Device Recall VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS

  • Model / Serial
    Item Number: 00-7843-013-07 Lot Numbers: 61946025 61735805 61993658 61768679 62029060 61815080 62043103 61879441 77000599 Item Number: 00-7843-015-07 Lot Number: 62135320 Item Number: 00-7843-016-17 Lot Numbers: 61879439 61993648
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
  • Product Description
    VERSYS 7.5 IN BEADED FC || +10 CALCAR 13.5X180MM STR || +10 CALCAR 15.5X180MM STR || +20 CALCAR 16.5X180MM STR || Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  • 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