Devices

Device Recall Oxford Fixed Bearing Partial Knee Replacement

  • Model / Serial
    M987290, M035670, 987410, M444830, M920680, M754840
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
  • Product Description
    REF 154221 Oxford Fixed Bearing Partial Knee || Cemented Lateral Tibia || Size D3 ARCOM UHMWPE / CO-CR-MO Alloy || Only for use in Lateral compartment || Sterile R || The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
  • 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

28 devices with a similar name

Learn more about the data here

Device Recall Oxford Fixed Bearing Partial Knee Replacement
  • Model / Serial
    M619730 , M480920, M656920, M938460, M444630
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
  • Product Description
    REF 154200 Oxford Fixed Bearing Partial Knee || Cemented Lateral Tibia || Size A3 ARCOM UHMWPE / CO-CR-MO Alloy || Only for use in Lateral compartment || Sterile R || The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
  • Manufacturer
    Biomet, Inc.
Device Recall Oxford Fixed Bearing Partial Knee Replacement
  • Model / Serial
    M619740, M492940, M444640, M656930, M938470
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
  • Product Description
    REF 154201 Oxford Fixed Bearing Partial Knee || Cemented Lateral Tibia || Size A4 ARCOM UHMWPE / CO-CR-MO Alloy || Only for use in Lateral compartment || Sterile R || The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
  • Manufacturer
    Biomet, Inc.
Device Recall Oxford Fixed Bearing Partial Knee Replacement
  • Model / Serial
    M879630 , M584360, M492950, M444650, M656940, M938480
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
  • Product Description
    REF 154202 Oxford Fixed Bearing Partial Knee || Cemented Lateral Tibia || Size A5 ARCOM UHMWPE / CO-CR-MO Alloy || Only for use in Lateral compartment || Sterile R || The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
  • Manufacturer
    Biomet, Inc.
Device Recall Oxford Fixed Bearing Partial Knee Replacement
  • Model / Serial
    M879640, M375460, M444660, M886350, M938490
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
  • Product Description
    REF 154203 Oxford Fixed Bearing Partial Knee || Cemented Lateral Tibia || Size A6 ARCOM UHMWPE / CO-CR-MO Alloy || Only for use in Lateral compartment || Sterile R || The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
  • Manufacturer
    Biomet, Inc.
Device Recall Oxford Fixed Bearing Partial Knee Replacement
  • Model / Serial
    M375470, M444680 , M886360, M938500
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
  • Product Description
    REF 154204 Oxford Fixed Bearing Partial Knee || Cemented Lateral Tibia || Size A7 ARCOM UHMWPE / CO-CR-MO Alloy || Only for use in Lateral compartment || Sterile R || The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
  • Manufacturer
    Biomet, Inc.
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