Device Recall Microvent

  • Model / Serial
    MicroVent Implant Line   Part # Description Lot Number Quantity MV3H10 Impl, M-V II, HA, 3.7mm, 10mm 0200515 100 MV3H10 Impl, M-V II, HA, 3.7mm, 10mm 0202923 100 MV3H13 Impl, M-V II, HA, 3.7mm, 13mm 014962 270 MV3H13 Impl, M-V II, HA, 3.7mm, 13mm 0200428 200 MV3H8 Impl, M-V II, HA, 3.7mm, 8mm 0202162 30 MV4H10 Impl, M-V II, HA, 4.7mm, 10mm 0200516 100 MV4H13 Impl, M-V II, HA, 4.7mm, 13mm 016646 100 MV4H13 Impl, M-V II, HA, 4.7mm, 13mm 0200427 100 MV4H8 Impl, M-V II, HA, 4.7mm, 8mm 0201180 35
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Product Description
    Microvent Implant Line
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer Dental Inc, 1900 Aston Ave, Carlsbad CA 92008-7308
  • Manufacturer Parent Company (2017)
  • 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