Events

Rappel de Device Recall Universal Titanium Prosthesis,

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 Xomed, 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
    66355
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2284-2013
  • Date de mise en oeuvre de l'événement
    2013-08-23
  • Date de publication de l'événement
    2013-09-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-11-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122139
  • 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
    Total & partial middle ear prostheses, ossicular - Product Code ETA
  • Cause
    One lot of the product was assembled using the cam head version of the same prosthesis instead of the round head shaft.
  • Action
    An "URGENT PRODUCT RECALL" letter was faxed to customers following the initial telephone notification. The letter described the product issue and provided recommended actions. Questions were directed to customer service at 800-874-5797.

Device

Device Recall Universal Titanium Prosthesis,
  • Modèle / numéro de série
    REF: 1150000 Lot: 0207029284
  • Classification du dispositif
    Ear, Nose, and Throat Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution (US), including the states of CA, NE, GA, and IL.
  • Description du dispositif
    Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
  • Manufacturer
    Medtronic Xomed, Inc.

Manufacturer

Medtronic Xomed, Inc.
  • Adresse du fabricant
    Medtronic Xomed, Inc., 6743 Southpoint Dr N, Jacksonville FL 32216-6218
  • 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