Device Recall SynviscOne

  • Modèle / numéro de série
    Lot Number: 7RSL021 Expiration Date: 2020-05-31
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide distribution(36 states)
  • Description du dispositif
    Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe || Product Usage: || A elastoviscous high molecular weight fluid containing hylan A and hylan B polymers produced from chicken combs. Synvisc-One is administered as a single intra-articular injection. Synvisc-One is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Sanofi Genzyme, 500 Kendall St, Cambridge MA 02142-1108
  • Société-mère du fabricant (2017)
  • Source
    USFDA