Devices

Device Recall PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices

  • Modèle / numéro de série
    Catalog Number 960015 Lot Numbers 7810268 and 7806929 (US) Lot Number 7806934 (OUS)
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution-USA including the states of IA, CA, KY, and FL, and the countries of Finland, Germany, Sweden, and Czech Republic.
  • Description du dispositif
    PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) || Used during primary total knee arthroplasty to improve patient mobility.
  • Manufacturer
    DePuy Orthopaedics, Inc.
  • 1 Event

Fabricant

DePuy Orthopaedics, Inc.
  • Adresse du fabricant
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA