Device Recall Drill Bits for Cervical Plate System

  • Modèle / numéro de série
    Lot Numbers: 89427-2 R & 89427-3-R
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including TX, IN, UT, AZ, GA, CA, AL, MI, and MN.
  • Description du dispositif
    Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: || "***Part Number CP40012***12mm Drill Bit***Lot Number 89427-2 R***" || "***Part Number CP40014***14mm Drill Bit***Lot Number 89427-3-R***" || The Captiva Spine SmartLOX Cervical Plate System is intended for the anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Captiva Spine, Inc, 967 Alternate A1A, Suite1, Jupiter FL 33477
  • Société-mère du fabricant (2017)
  • Source
    USFDA