Device Recall Sutures, Nonabsorbable, Silk, Sterile

  • Modèle / numéro de série
    Product Code: X-6371M5, Lot numbers: 02E0801603
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
  • Description du dispositif
    Sutures, Non-absorbable, Silk, Sterile, Rx only, || Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural non-absorbable silk surgical suture is indicated for use in soft tissue approximation. Natural non-absorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Non-absorbable Surgical Suture (class I). Natural non-absorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Teleflex Medical, 2917 Weck Dr., Research Triangle Park NC 27709
  • Société-mère du fabricant (2017)
  • Source
    USFDA