Rappel de Medtronic Sofamor Danek,Medtronic Sofamor Danek, Satellite Spinal System Instruments

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 Medtronic Sofamor Danek USA 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
    44967
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0210-2008
  • Date de mise en oeuvre de l'événement
    2007-09-13
  • Date de publication de l'événement
    2007-12-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2009-08-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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
    Spinal System - Product Code LXH
  • Cause
    Marketed without approval: the surgical technique includes reference to an 8mm trial and 8mm curette, while the cleared -510 (k)- device only includes spheres between 9.5 and 19 mm.
  • Action
    On September 12, 2007, the recalling firm's representatives were instructed by electronic mail to remove any manuals in the field and contact surgeons who have evaluated, implanted or been trained to implant the Satellite System and to collect any guides they may have on site. The sales representatives that have accounts where the Satellite product was shipped directly were mailed the information and instructed to hand deliver the 9/13/07, Urgent Device Recall notices to each consignees risk management office. The recall was then expanded on 10/31/2007, to include the surgical manual, the implants and associated instruments. The delivery of the second Urgent Device Recall Notices, dated 10/25/07, were handled in three ways: 1) The letter was delivered to all initial consignees that received satellite products along with a questionnaire (response card) to be completed by the Risk Manager or equivalent administrative function., 2) The letter without the questionnaire was sent directly to target surgeons who are known to have implanted or have been trained to implant Satellite Product 3) a field action confirmation form was sent to Sales Representative with surgeon customers that are receiving the recall communication. The form will be completed by the Sales Representative to confirm the surgeons have received the recall communication and have returned any of the surgical techniques and instruments.

Device

  • Modèle / numéro de série
    ALL LOTS to include: NM04H0021, NM04H0051, NM04H005Z, NM04H0321
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    Medtronic Sofamor Danek, 8 mm Trial, size 8 mm, Material Stainless Steel/Radel, quantity 1 each, Non-sterile, Rx only, REF 8004208, Manufactured at: Bartlett, Tennessee, USA
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Medtronic Sofamor Danek USA Inc, 1800 Pyramid Place, Memphis TN 38132-1719
  • Source
    USFDA