Device Recall Biomet brand Modular Microplasty Cup Inserter

  • Modèle / numéro de série
    Lot 097525, 097526, 532370 and 532810.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Australia, Belgium, Canada, Denmark, New Zealand and Sweden.
  • Description du dispositif
    Biomet brand Modular Microplasty Cup Inserter, 3/8" thread, Biomet Orthopedics, Inc., Warsaw, IN; Model 31-400600. Non-powered, hand-held instrument intended for use as an impactor during 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

En savoir plus sur les données ici

  • Modèle / numéro de série
    Lots: 095116, 095117, 096758, 0967822 and 096824.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA, Germany, Mexico, Netherlands, Sweden and United Kingdom.
  • Description du dispositif
    Biomet brand Modular Microplasty Cup Inserter, 3/8" thread; Model 31-400600 assembled with a 3/8" threaded insert; Model 31-400603. Instrument for hip prosthesis acetabular cup component.
  • Manufacturer