Events

Rappel de MicroAire SmartRelease Endoscopic System

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 MicroAire Surgical Instruments, LLC.

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
    80095
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2107-2018
  • Date de mise en oeuvre de l'événement
    2018-04-19
  • Date de publication de l'événement
    2018-05-25
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164550
  • 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
    Arthroscope - Product Code HRX
  • Cause
    The instructions for use (ifu) is incorrect with regards to sterilization parameters and must be replaced.
  • Action
    Urgent Medical Device Recall letters were distributed to customers. The letters instructed customers to do the following: If you have some quantity of IFUs remaining, we're asking you to destroy your current copies, IM-SMARTRELEASE Rev. A-D, and replace them by going on-line at MicroAire at www.microaire.com/resources. Click Carpal Tunnel, then SmartRelease Instruction Manual to obtain the latest version, IM-SMARTRELEASE Rev. E. Please complete and send back page two of this letter to notification@microaire.com or via fax at 800-648-4309. If you have no quantity of IFUs remaining, there are no further activities needed by you except for the mandatory returning of page two of this letter to notification@microaire.com or via fax at 800-648-4309. For further questions, please call (800) 722-0822.

Device

MicroAire SmartRelease Endoscopic System
  • Modèle / numéro de série
    All products distributed from 1/1/13 to 2/23/18
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of: Australia, Belgium, Brazil, Canada, Chile, Czech Republic, Denmark, France, Germany, Hong Kong, India, Iran, Ireland, Israel, Italy, Jordan, Korea, Lebanon, Mexico, Nicaragua, Poland, Russia, Saudi Arabia, Serbia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, and UK.
  • Description du dispositif
    MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D || The MicroAire Carpal Tunnel Release System is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any other known pathology (i.e., idiopathic carpal tunnel syndrome). Preoperative x-rays of the wrist, including a carpal tunnel view, are recommended to aid in the diagnosis of associated pathology (i.e., calcific tendonitis, fracture of the hook of the hamate). This device is indicated for releasing the transverse carpal ligament (flexor retinaculum).
  • Manufacturer
    MicroAire Surgical Instruments, LLC

Manufacturer

MicroAire Surgical Instruments, LLC
  • Adresse du fabricant
    MicroAire Surgical Instruments, LLC, 3590 Grand Forks Blvd, Charlottesville VA 22911-9006
  • Société-mère du fabricant (2017)
    Colson Associates Inc.
  • Source
    USFDA