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

  • Model / Serial
    Catalog Number 960015 Lot Numbers 7810268 and 7806929 (US) Lot Number 7806934 (OUS)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA including the states of IA, CA, KY, and FL, and the countries of Finland, Germany, Sweden, and Czech Republic.
  • Product Description
    PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) || Used during primary total knee arthroplasty to improve patient mobility.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Manufacturer Parent Company (2017)
  • Source
    USFDA