Device Recall Triathlon Revision Knee

  • Model / Serial
    Catalog 5521-B-300, lot code ATV7IA Catalog 5521-B-400, lot code ATY40A
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Affected products were sent to three medical facilities. Affected product will be returned to the manufacturer for disposition.
  • Product Description
    Knee Prosthesis, Sterile, Single-Use devices || Product Usage: || The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Catalog #5545-A-301, lot code ER9WA1A, ER9WA1D, ER9WA1E Catalog #5546-A-601, lot code ER9MA5A
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA (nationwide) Distribution to the states of : AL, AZ, CA, FL, GA, KS, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA
  • Product Description
    Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 || The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function.
  • Manufacturer