Events

Rappel de Device Recall SwiftLock Anchor, Model 1192

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 Advanced Neuromodulation Systems, 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
    55142
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1425-2010
  • Date de mise en oeuvre de l'événement
    2010-02-22
  • Date de publication de l'événement
    2010-04-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-07-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90025
  • 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
    stimulator, spinal-cord, implanted (pain relief) - Product Code GZB
  • Cause
    Directions for use of product incorrectly stated lead compatibility information.
  • Action
    An "Urgent Medical Device Correction" letter dated March 8, 2010, was sent to the customers (note: Firm verbally informed consignees on February 22, 2010.). The letter describes the product, problem and action to be taken by the firm -St. Jude Medical. The firm's Sales Representatives will contact the customers to update any DFUs in their possession. If you need additional copies of the insert or more information and if you have any questions or concerns, please contact your St. Jude Medical Sales Representative at 1-651-490-4470.

Device

Device Recall SwiftLock Anchor, Model 1192
  • Modèle / numéro de série
    All lots.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide distribution: AZ, CA, CO, DC, FL, GA, IL, IN, MI, MO, MS, NC, NM, NJ, NV, NY, OH, OK, OR, PA, SC, TN, WA AND WV.
  • Description du dispositif
    Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude Medical Company. || Product is intended to be used as an accessory to the leads component of ANS SCS systems, functioning to secure the lead to the fascia or interspinous/supraspinous ligament.
  • Manufacturer
    Advanced Neuromodulation Systems, Inc

Manufacturer

Advanced Neuromodulation Systems, Inc
  • Adresse du fabricant
    Advanced Neuromodulation Systems, Inc, 6901 Preston Rd, Plano TX 75024-2508
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA