Device Recall Restorelle DirectFix Posterior Mesh

  • Modèle / numéro de série
    Lot numbers : 2936642, 2967400.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    USA ( nationwide) including the states of AL, AZ, AR, CA, CO, FL, GA, ID, IL, KY, MD, MS, MO, NY, PA, TN, VA,WA and WI.
  • Description du dispositif
    Coloplast, Restorelle DirectFix, Posterior Polypropylene Mesh, Catalogue Number 501460, Rx Only, Manufacturer, Coloplast A/S 3050 Denmark || Restorelle is a ploypropylene mesh that may be used for the repair of abdominal wall hernia, including inguinal, fermoral, and incisional, and uterovaginal proplapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Coloplast Manufacturing US, LLC, 1601 W River Rd, Minneapolis MN 55411-3431
  • Société-mère du fabricant (2017)
  • Source
    USFDA