Events

Rappel de Device Recall Accessories for the Captiva Spine SmartLOX Cervical Plate System.

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Captiva Spine, Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    61811
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1649-2012
  • Date de mise en oeuvre de l'événement
    2011-11-22
  • Date de publication de l'événement
    2012-05-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-11-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109149
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • Cause
    Captiva spine is recalling the smartlox cervical plate components 12 & 14 mm drill bits, single barrel variable drill guides, and double barrel fixed drill guides. the components are part of the instrumentation kit used to complete an anterior screw fixation of the cervical spine. there is a potential risk for the drills to not properly fit through the drill guides due to an overlap in the dime.
  • Action
    Captiva Spine notified customers of the recall by letter on November 23, 2011, and advised that the affected products would be replaced. Customers were asked to return the drill guides and unused drills with the provided return labels. For questions customers should call 877-772-5571. For questions regarding this recall call 561-277-9480.

Device

Device Recall Accessories for the Captiva Spine SmartLOX Cervical Plate System.
  • Modèle / numéro de série
    Lot Numbers: 1500705A, 06110041, 1500707A, 06110043, 1500708A, and 06110044
  • Classification du dispositif
    Orthopedic Devices
  • 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 CP50150***Single Barrel Variable Drill Guide***Lot Number 1500705A or Lot Number 06110041***" || "***Part Number CP50160***Single Barrel Fixed Drill Guide***Lot Number 1500707A or Lot Number 06110043***" || "***Part Number CP50170***Double Barrel Fixed Drill Guide***Lot Number 1500708A or Lot Number 06110044***" || Products are packaged individually and shipped as replacement parts to be placed in the SmartLOX Cervical Plate System tray. || 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
    Captiva Spine, Inc

Manufacturer

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