Device Recall Palacos R

  • Model / Serial
    All lots.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    United States
  • Product Description
    Palacos R radiopaque bone cement, 40 gram. Product number 424800.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Biomet Inc, 56 East Bell Dr, Warsaw IN 46582
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Cat No. 00-1113-140-01; lot 75974340
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI, WV & WY.
  • Product Description
    Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl Methacrylate Monomer 0.5 g Gentamicin, Distributed by Zimmer Dover, OH 44522 || The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.
  • Manufacturer