Events

Rappel de Device Recall Tra, Surgical, ENT

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
    65837
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1934-2013
  • Date de mise en oeuvre de l'événement
    2013-07-09
  • Date de publication de l'événement
    2013-08-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-09-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120407
  • 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
    Tray, surgical, ent - Product Code MMO
  • Cause
    The firm will recall and replace the identified instrument trays in the field, with trays that have improved labeling, including lids that contain the statement indicating 'prevacuum only".
  • Action
    Medtronic sent a Customer Commincation Recall Letter to all affected customers with the following information: Subject: URGENT PRODUCT Recall  Immediate Attention Required MEDTRONIC XOMED INSTRUMENT TRAYS - model numbers provided on Attachment One - all lots distributed prior to July 2013 Dear Purchasing Manager, Risk Manager and Central Supply Manager/Supervisor: This letter is to inform you that Medtronic Surgical Technologies (ENT Division) is initiating a voluntary recall to remove certain instrument trays from the field and replace them with trays that have modified labeling. Medtronic Xomed Instrument Trays are intended for the storage and transportation of reusable surgical instruments. These trays are not intended and not designed to maintain sterility. We are aware, however, that some users may also choose to use the trays for holding instruments during steam sterilization. If the user chooses to sterilize instruments within these instrument trays, they must validate the sterilization process. These users should be aware of the following issue: Issue Description: During the validation of a new instrument, testing revealed that use of a GRAVITY steam cycle with one of the listed instrument trays did not produce the Sterility Assurance Level (SAL) of 10-6 recommended by industry standard (ANSI/AAMI ST77:2006). A subsequent investigation of all Medtronic Xomed instrument trays identified additional trays as having certain locations within the tray that would not meet the recommended sterilization level of SAL10-6 during GRAVITY steam sterilization cycles. The trays identified through the testing are the subject trays involved in this field action. Instruments that are sterilized in the worst-case locations of the identified trays have a higher potential to be inadequately sterilized. An instrument that is inadequately sterilized can become the source of cross-contamination or cross-infection when used in multiple surgical procedures. At this time

Device

Device Recall Tra, Surgical, ENT
  • Modèle / numéro de série
    ALL Lots of the following models: Model 3717000 = 2 Level Instrument tray Model 3717001 = 3 Level tray (metal & radel) Model 3717006 = 2 Level Instruument tray with mat Model 3717026 = House Otology Set tray Model 3722301 = Wiet Chronic Ear Set tray Model 3747108 = Skykes Endobrow Lift tray Model 960374 = framelock tray Model *960-811 = Framelock Instrument set (includes tray 9603740 Model 960-619 = LandmarX tray Model *9731372XOM1 = Passive ENT Instrument Set (w/tray 960-619) Model MCOH0SC = Otology Plastic instrument tray Model MCO649SC = Middle Ear Instrument tray Model MCOS10SC = Instrument tray 2 level Model MCLS28 = MF Sataloff Complete Instrument tray Model MCLS37 = Sataloff Picks/Handles/Neddles Instrument tray Model 3319005 = Powerforma Bur Rack tray  * instrument set that includes the identified tray
  • Classification du dispositif
    Ear, Nose, and Throat Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Nationwide, Hawaii, Puerto Rico and Guam. Internationally to: Canada, Austria, Belgium, Cyprus, France, Germany, Greece, India, Iran, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Morocco, Netherlands, Nigeria, Portugal, Qatar, Reunion, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Australia, New Zealand, Singapore, Thailand, Vietnam, China, Hong Kong,Taiwan, Korea, Japan, Brazil, Chile, Colombia, Costa Rica, Ecuador, Guatemala, Mexico, Nicaragua, and Venezuela.
  • Description du dispositif
    Tray Surgical, ENT (various instrument trays) || Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures.
  • 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