Events

Rappel de Device Recall Saw Sagittal

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 - Dallas Distribution.

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
    74275
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2085-2016
  • Date de mise en oeuvre de l'événement
    2016-05-13
  • Date de publication de l'événement
    2016-06-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147047
  • 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
    Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
  • Cause
    Medtronic powered surgical solutions testing of the sagittal saw rocker arm seal identified a potential for leakage of fluid into the motor during use.
  • Action
    Recall notification letters were sent to consignees on 05/13/2016.

Device

Device Recall Saw Sagittal
  • Modèle / numéro de série
    All Serial Numbers.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-Including the states of AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, MA, MD, NC, NH, NY, SC, TN, TX, and UT.
  • Description du dispositif
    Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: ES310-R; Used to dissect bone in surgical applications.
  • Manufacturer
    Medtronic Sofamor Danek Usa, Inc - Dallas Distribution

Manufacturer

Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
  • Adresse du fabricant
    Medtronic Sofamor Danek Usa, Inc - Dallas Distribution, 4620 N Beach St, Haltom City TX 76137-3219
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA