Devices

Device Recall Stryker CORE

  • Modèle / numéro de série
    Lot numbers: 15077027, 15077067, 15077097, 15078087, 15105017, 15108017, 15108047, 15108077, 15108087, 15108097, 15146017, 15146027, 15146037, 15146047
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) Netherlands, Canada, Japan, Switzerland, and United Kingdom
  • Description du dispositif
    2.3MM Tapered Router, || Product Number 5407-FA2-023 || A router is a cutting accessory used in the following medical applications: Neuro; Spine; Ear, Nose, and Throat || (ENT)/Otology /Neurotology/ Otorhinolaryngology; Craniofacial (bones of the skull and supraorbital region); and || Sternotomy. They are intended to be used with the Stryker CORE" system.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation
  • 1 Event

Fabricant

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