Events

Rappel de CONFIDENCE SPINAL CEMENT SYSTEM KIT

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 DePuy 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
    64937
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2134-2013
  • Date de mise en oeuvre de l'événement
    2013-04-17
  • Date de publication de l'événement
    2013-09-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-08-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117466
  • 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
    Cement, bone, vertebroplasty - Product Code NDN
  • Cause
    During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.
  • Action
    DePut Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated April 15, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the con signee. Consignees were instructed to review their inventory and quarantine for return any products listed in the recall notice., complete the enclosed Business Reply Form, indicating level of inventory of the affected product and return the form to Depuy via fax to 888-943-4897or email to DePuy7862@stericycle.com and to return the product with the enclosed UPS label to Stericycle. For questions regarding this recall call 508-977-6606.

Device

CONFIDENCE SPINAL CEMENT SYSTEM KIT
  • Modèle / numéro de série
    HPBB0B, HPBBWM, HPCB75, HPCCBN, HPBB0R, HPBBWP, HPCB7D, HPDBBV, HPBB28, HPBBZ7, HPCB7F, HPDBCG, HPBB2D, HPBBZF, HPCB7T, HPDBD1, HPBB2F, HPBCKH, HPCB7V, HPDBD5, HPBB4R, HPBDL9, HPCB8G, HPDBF9, HPBBV1, HPCB67, HPCBLC, HPDBGH, HPBBWG, HPCB68, HPCBM1, HPDBGK, HPBBWK, HPCB74, HPCCBM, HPDBGL
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV, WY; Worldwide: Algeria, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, France, Germany, Hong Kong, India, Israel, Italy, Latvia, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UAE, and UK
  • Description du dispositif
    CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 || The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.
  • Manufacturer
    DePuy Spine, Inc.

Manufacturer

DePuy Spine, Inc.
  • Adresse du fabricant
    DePuy Spine, Inc., 325 Paramount Dr, Raynham MA 02767-5199
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA