Devices

Device Recall Mallory Head Calcar Provisional

  • Model / Serial
    Lot Number: M553140.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States (OH, IN, FL, KY, NV and CA), Mexico, Chile, China, Japan and The Netherlands.
  • Product Description
    Mallory Head Calcar Provisional, 45 mm replacement stem, 13.0 x 220 mm left, Sterile, REF 104986, Biomet Orthopaedics, Warsaw, IN. || Implant device intended for use in femoral revision surgery.
  • Manufacturer
    Biomet, Inc.
  • 1 Event

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582
  • 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 Mallory Head Calcar Provisional
  • Model / Serial
    Lot Number: M997990.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States (OH, IN, FL, KY, NV and CA), Mexico, Chile, China, Japan and The Netherlands.
  • Product Description
    Mallory Head Calcar Provisional, 34 mm replacement stem, 11 mm x 220 mm left, Sterile, REF 104773, Biomet Orthopaedics, Warsaw, IN. || Implant device intended for use in femoral revision surgery.
  • Manufacturer
    Biomet, Inc.
Device Recall Mallory Head Calcar Provisional
  • Model / Serial
    Lot Number: M059030.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States (OH, IN, FL, KY, NV and CA), Mexico, Chile, China, Japan and The Netherlands.
  • Product Description
    Mallory Head Calcar Provisional, 55 mm resection/porous coated, 17.0 mm x 260 mm left, Sterile, REF 11-104939, Biomet Orthopaedics, Warsaw, IN. || Implant device intended for use in femoral revision surgery.
  • Manufacturer
    Biomet, Inc.