Devices

Device Recall Triathlon Revision Knee

  • Modèle / numéro de série
    Catalog 5521-B-300, lot code ATV7IA Catalog 5521-B-400, lot code ATY40A
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Affected products were sent to three medical facilities. Affected product will be returned to the manufacturer for disposition.
  • Description du dispositif
    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
    Howmedica Osteonics Corp.
  • 1 Event

Fabricant

Howmedica Osteonics Corp.
  • Adresse du fabricant
    Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA

Un dispositif médical avec un nom similaire

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Device Recall Triathlon Revision Knee
  • Modèle / numéro de série
    Catalog #5545-A-301, lot code ER9WA1A, ER9WA1D, ER9WA1E Catalog #5546-A-601, lot code ER9MA5A
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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
  • Description du dispositif
    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
    Howmedica Osteonics Corp.