Events

Rappel de Norian CRS Rotary Mixer Cement 10cc sterile

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 Synthes USA (HQ), 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
    53496
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0269-2010
  • Date de mise en oeuvre de l'événement
    2009-09-14
  • Date de publication de l'événement
    2009-11-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-03-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85637
  • 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
    Methyl Methacrylate For Cranioplasty - Product Code GXP
  • Cause
    Non-conforming material - increased set time. potential clinical ramifications associated with increased set time and decreased strength include extrusion of unset material and fragmentation of cured material. the risk of norian fragmentation post cure increases with a larger defect and a thicker layer of product. customers were advised to call synthes at 1-800-479-6329 to obtain a return autho.
  • Action
    The firm issued an Urgent Medical Device Recall letter dated 9/17/09 via USPS certified mail. The letter informed customers of the problem and the need to return the product. Sales Consultants that were shipped the device were notified by teleconference on 9/14/09. Consultants were instructed to go to their accounts to remove the product from inventory. Customers were advised to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Questions are directed to Synthes at 800-620-7025 x 5453 or 610-719-5453 or to your Synthes CMF Sales Consultant.

Device

Norian CRS Rotary Mixer Cement 10cc sterile
  • Modèle / numéro de série
    Catalog number 614.10.01S. Lot number N996352
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    The product was shipped to medical facilities in CO, KS, MA, MO, NY, SC, TX, UT, and WA.
  • Description du dispositif
    Norian CRS Rotary Mixer Cement 10cc sterile
  • Manufacturer
    Synthes USA (HQ), Inc.

Manufacturer

Synthes USA (HQ), Inc.
  • Adresse du fabricant
    Synthes USA (HQ), Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA