Device Recall ZMS Intramedullary Fixation Smooth Guide Wire

  • Modèle / numéro de série
    Lot Numbers:  63645655 63650115 63650116 63655995 63655996 63655997 63655998
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
  • Description du dispositif
    ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip || 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-038-00
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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 Numbers:  63662549 63668704 63696974 63709171 63721377 63731176 63764550 63771164 63781920 63803595 63812302 63817719 63826242
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
  • Description du dispositif
    ZMS Intramedullary Fixation Smooth Guide Wire || 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-037-00
  • Manufacturer
  • Modèle / numéro de série
    Lot Numbers:  63715690 63780127 63787482
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
  • Description du dispositif
    ZMS Intramedullary Fixation Smooth Guide Wire || 2.4 mm Diameter, 100 cm Length; Item Number: 47-2237-033-00
  • Manufacturer