Device Recall OSS Letson Proximal Femoral Trial 7 cm

  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- USA, Australia, Belgium, Canada, Costa Rica, Finland, France, Germany, Mexico, New Zealand, Poland, South Wales, and Spain.
  • Description du dispositif
    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
  • 1 Event

Fabricant

  • Adresse du fabricant
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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

Un dispositif médical avec un nom similaire

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  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- USA, Australia, Belgium, Canada, Costa Rica, Finland, France, Germany, Mexico, New Zealand, Poland, South Wales, and Spain.
  • Description du dispositif
    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