Events

Rappel de Device Recall ATLANTIS (R) SelfTapping Variable Angle Screw

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
    59021
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2878-2011
  • Date de mise en oeuvre de l'événement
    2011-06-28
  • Date de publication de l'événement
    2011-07-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-12-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100846
  • 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
    Appliance, fixation, spinal intervertebral body - Product Code KWP
  • Cause
    Screws are longer then size etched on the screw.
  • Action
    Medtronic sent a Voluntary Recall letter dated June 28, 2011, directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included. The letter identified the product, the problem, and the action to be taken by the affected customers. If appropriate, personal follow up with Sales Representatives will be made to assure that the recall communication is understood by Risk Managers and to facilitate return of product and the associated Recall response documentation. Foreign consignees will be notified by email on June 29, 2011. For any questions or concerns regarding this recall customers were to contact their Medtronic Sales Representative or the Global Quality Department at 800-876-3133, ext 3173.

Device

Device Recall ATLANTIS (R) SelfTapping Variable Angle Screw
  • Modèle / numéro de série
    Lot number H10A1268
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of MN, AK, FL, PA, ME, GA HI, CA, TX, OH, IN, MO, WI, MI, NY, IN, LA, MD, MA, NC, OR, NE WA, ID, CO, OR, UT, IL, WV, Canada, Singapore, Netherlands, Brazil, Columbia, Hong Kong, and Mexico.
  • Description du dispositif
    ATLANTIS (R) Self-Tapping Variable Angle Screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 || Intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
  • Manufacturer
    Medtronic Sofamor Danek USA Inc

Manufacturer

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