Device Recall DePuy CEMENT RESTRICTOR, Size 3

  • Model / Serial
    Product Code 546014000, Lot s ET5EA4 and ET5EB4, Size 3.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution including the states of MA, PA, FL, LA, MN, WA, WI, CO, GA, NY, NC and SC and the countries of Canada, Colombia, Ireland and Argentina.
  • Product Description
    DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 3, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral hip prosthesis.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Depuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Source
    USFDA