Device Recall Mallory Head Calcar Provisional

  • Modèle / numéro de série
    Lot Number: M059030.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- United States (OH, IN, FL, KY, NV and CA), Mexico, Chile, China, Japan and The Netherlands.
  • Description du dispositif
    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
  • 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

2 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Lot Number: M997990.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- United States (OH, IN, FL, KY, NV and CA), Mexico, Chile, China, Japan and The Netherlands.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Lot Number: M553140.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- United States (OH, IN, FL, KY, NV and CA), Mexico, Chile, China, Japan and The Netherlands.
  • Description du dispositif
    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