Devices

Device Recall Biomet Offset Tibial Tray Adaptor

  • Model / Serial
    Catalog Number: 141490 Lot 378330,378320,407230,485010,505140,485000,506070,533400,54048, 439700,797820
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution - USA (nationwide) and the countries of Australia, Canada, Chile, Europe, Japan, Korea, Panama, Puerto Rico and Thailand.
  • Product Description
    Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 || Sterile, QTY.1 || Product Usage: || Knee joint replacement prostheses intended for application with or without bone cement. Knee joint replacement components include femoral, tibial, and patellar components, intended for both primary and revision applications. Indications: 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis when one or more compartments are involved, 2) correction of varus, valgus, or posttraumatic deformity, 3) correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure
  • Manufacturer
    Biomet, Inc.
  • 1 Event

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    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

One device with a similar name

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Device Recall Biomet Offset Tibial Tray Adaptor
  • Model / Serial
    Lot 644290.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution including Germany, Italy, Netherlands, Spain and the United Kingdom.
  • Product Description
    Biomet Offset Tibial Tray Adaptor, 5.0 MM, sterile, Biomet Orthopedics, Inc., Warsaw, IN, REF 141491. || The Biomet Offset Tibial Tray Adaptor is a knee prosthesis intended for cemented use in patients with the following indications: painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved, correction of valgus, varus or posttraumatic deformity, correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
  • Manufacturer
    Biomet, Inc.