Device Recall SMARTSET GHV Gentamicin Bone Cement

  • Modelo / Serial
    Cat. No. 545035500, Lot No. 7915797
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MS, MT, NC, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WV.
  • Descripción del producto
    SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but relies instead on close mechanical interlock between the irregular bone surface and the prosthesis.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA