Device Recall Imbibe Aliquot Needle Bone Cement Needle

  • Modèle / numéro de série
    all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle Catalog No.: 2110-0505, 2110-0506, 2110-0524, 2110-0529.
  • 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 Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch || 2110-0524 Beveled Needle, 11 gauge x 6 inch || 2110-0506 Diamond Needle, 11 gauge x 4 inch || 2110-0529 Diamond Needle, 11 gauge x 6 inch || Intended Use: Can be used in either direct (or open) and percutaneous (or deep) delivery of bone cement.
  • 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