Device Recall GalaSHAPE 3D

  • Modèle / numéro de série
    Lot Number: 160294
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution to IN, CA, FL, MI, NV, and MT
  • Description du dispositif
    GalaSHAPE 3D; product code SH3D03, a medium size oval || GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. GalaSHAPE" 3D is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Tepha Incorporated, 99 Hayden Ave Ste 360, Lexington MA 02421-7966
  • Société-mère du fabricant (2017)
  • Source
    USFDA