Events

Rappel de Device Recall Synthes Power Drive.

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 U S A.

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
    49039
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2395-2008
  • Date de mise en oeuvre de l'événement
    2008-07-23
  • Date de publication de l'événement
    2008-09-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-05-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72569
  • 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
    Motor, surgical instrument, ac-powered - Product Code GEY
  • Cause
    The product is mislabeled, as the validation for the previous sterilization parameters cannot be replicated. the currently validated sterilization parameter is a minium of 24 minutes prevacuum.
  • Action
    All Synthes Trauma customers and sales consultant s were notified of the correction via return receipt letters sent via UPS. This notification communication contains product literature documenting the validated sterilization parameters. Instructions detail disposal of the previously received literature and replacement with the provided literature. A toll free number with a dedicated extension has been established for questions. The firm has requested that all recipients acknowledge understanding of instructions by returning a Verification Section via fax or email. If you have questions, call 800-620-7025 ext 5450, 610-719-5450 or contact your Synthes Sales Consultant.

Device

Device Recall Synthes Power Drive.
  • Modèle / numéro de série
    Catalog number 530.100. All lot numbers
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    The product was shipped to medical facilities and sales consultants nationwide. The product was also shipped to Canada.
  • Description du dispositif
    Power Drive. Battery-driven power tool system intended for use during surgical procedures to provide power to operate various accessories and attachments.
  • Manufacturer
    Synthes U S A

Manufacturer

Synthes U S A
  • Adresse du fabricant
    Synthes U S A, 1302 Wrights Ln, West Chester PA 19380-3401
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA