Device Recall Imbibe Bone Marrow Aspiration Needle

  • Modèle / numéro de série
    all lots of the Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Catalog No.: 2090-0027, 2090-0028, 2090-0029, 2090-0030, 2090-0047
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and country of: Canada.
  • Description du dispositif
    Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: 2090-0027 Needle (bullet-tip), 11 gauge x 4 inch || 2090-0028 Needle (bullet-tip), 11 gauge x 6 inch || 2090-0029 Needle (bullet-tip), 8 gauge x 6 inch || 2090-0047 Needle (bullet-tip), 8 gauge x 8 inch || 2090-0030 Needle (bullet-tip), Fenestrated, 8 gauge x 6 inch || intended for use to aspirate bone marrow or autologous blood.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Orthovita, Inc., dBA Stryker Orthobiologics., 45 Great Valley Pkwy, Malvern PA 19355-1302
  • Société-mère du fabricant (2017)
  • Source
    USFDA