Device Recall Stryker 3.0mm x 3.8mm Precision Neuro Drill

  • Modèle / numéro de série
    Part Number 5820-107-530, Lot Number 13332017, 13332027, 13332037, 13333017, 13333027, 13334017, 13334027, 13336017, 13336027, 13346017, 13347017, 13347027, 13347037, 14017017
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide)
  • Description du dispositif
    Stryker 3.0mm x 3.8mm Precision Neuro Drill || Sterile || Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Société-mère du fabricant (2017)
  • Source
    USFDA