Device Recall INSORB 2030 Subcuticular Skin Stapler

  • Modèle / numéro de série
    Lot 121901
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    International Distribution Only - Turkey.
  • Description du dispositif
    Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids. It is chemically similar to other surgical glycolide/lactide-based copolymers. Polyglycolic/polylactic acid copolymers degrade in vivo by hydrolysis to glycolic acid and lactic acid which are then absorbed and metabolized by the body.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Incisive Surgical Inc, 14405 21st Ave N, Plymouth MN 55447-4685
  • Société-mère du fabricant (2017)
  • Source
    USFDA