Devices

Device Recall OSS Letson Proximal Femoral Trial 7 cm

  • Model / Serial
    All lots. Lots 063960, 115390, 115460, 197210, 206280, 238310, 252780, 397280, 405110, 444100, 444110, 488440, 506470, 536100, 632470, 635860, 641450, 721420, 775240, 793530, 797790, 839640, 849140, 892440, 894240 and 895840.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA, Australia, Belgium, Canada, Costa Rica, Finland, France, Germany, Mexico, New Zealand, Poland, South Wales, and Spain.
  • Product Description
    Biomet OSS Letson Proximal Femoral Trial 7 cm resection/left, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472089. || A non-powered, orthopedic manual surgical instrument for use with other devices in orthopedic 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

One device with a similar name

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Device Recall OSS Letson Proximal Femoral Trial 7 cm
  • Model / Serial
    All lots. Lots 115380, 115450, 244950, 283940, 331420, 397270, 444090, 448960, 484400, 488430, 506460, 619850, 721410, 723490, 741860, 744110, 824890, 849130, 855740, 889880, 895820, 895830, 924860 and 976300.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA, Australia, Belgium, Canada, Costa Rica, Finland, France, Germany, Mexico, New Zealand, Poland, South Wales, and Spain.
  • Product Description
    Biomet OSS Letson Proximal Femoral Trial 7 cm resection/right, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472088. || A non-powered, orthopedic manual surgical instrument for use with other devices in orthopedic surgery.
  • Manufacturer
    Biomet, Inc.