Events

Rappel de Device Recall Hemostatic Bone Putty

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, 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
    70055
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1094-2015
  • Date de mise en oeuvre de l'événement
    2012-01-06
  • Date de publication de l'événement
    2015-02-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-03-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132283
  • 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
    Wax,bone - Product Code MTJ
  • Cause
    Revision a of the hemostatic bone putty brochure (j10847a) was sent to sales consultants instead of revision b (j10847b), which corrected an error in the indication statement.
  • Action
    On/about 12/22/2011, emails containing Revision B brochure, as well as instructions to delete/destroy Revision A, were sent to 38 affected individuals (sales consultants). On/about 1/04/2012, follow up phone calls were made to each member of the sales force who had received Rev. A (110847 A) to confirm that they had replaced the Rev. A with the Rev. B (110847 B). In addition, the members of the sales force were asked whether or not the Rev. A had been disseminated to any HCP's. During the follow up conversation, one member of the sales force stated that he had provided the previous version to a surgeon. On 01/06/2012, the sales consultant spoke to the surgeon in person and the surgeon confirmed that he had disposed of the Rev. A.

Device

Device Recall Hemostatic Bone Putty
  • Modèle / numéro de série
    Part 10847A
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed in the state of WI
  • Description du dispositif
    Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
  • Manufacturer
    Synthes, Inc.

Manufacturer

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