Events

Rappel de Device Recall Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100

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
    67267
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0977-2014
  • Date de mise en oeuvre de l'événement
    2014-01-06
  • Date de publication de l'événement
    2014-02-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-06-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125127
  • 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
    Filler, bone void, osteoinduction (w/o human growth factor) - Product Code MBP
  • Cause
    Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2.5 cm x 5 cm.
  • Action
    The firm, Medtronic, sent an "URGENT-V voluntary Market Removal (Recall)" communication letter and questionnaire packet (via FedEx) dated January 3, 2014 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to remove the product from normal storage locations; Do not use the product; and as applicable, contact your Medtronic Sales Representative to coordinate the return and replenishment of affected product or call our Global Quality Department at 800-876-3133 ext 3197. In addition, the customers were instructed to disseminate this information to additional personnel within your facility as appropriate. A Medtronic Sales Representative will contact you to facilitate the return of any impacted Set Screw Retaining Drivers you may have in your possession. If you need assistance or if you have any related questions or concerns, please do not hesitate to contact your Medtronic Sales Representative or our Global Quality Department at 800-876-3133 extension 3197.

Device

Device Recall Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100
  • Modèle / numéro de série
    A16707-098, A16707-099, A16707-100, A16707-101, A16707-102, A16707-103, A16707-104, A16707-105, A16707-106, A16707-107, A16707-108, A16707-109, A16707-110, A16707-111, A16707-112, A16707-113, A16707-114, A16707-115, A16707-116, A16707-117, A16707-118, A16707-119, A16707-120, A16707-121, A16707-122, A16707-123, A16707-124, A16707-125, A16707-142, and A16707-147
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution in the states of: MO, FL, MN, OH, MI, TX, and NJ.
  • Description du dispositif
    Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132 || Orthopaedic - filler, bone void
  • 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