Events

Rappel de Device Recall smith & nephew

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 Smith & Nephew, Inc., Endoscopy Div..

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
    72911
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0818-2016
  • Date de mise en oeuvre de l'événement
    2013-07-30
  • 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=142484
  • 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
    Accessories,arthroscopic - Product Code NBH
  • Cause
    During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigation extender separates, potentially obstructing visualization and causing leakage of the irrigation fluid. the device is removed and a back-up device is used to complete the surgery.
  • Action
    Urgent - Product Recall 1st Notification - Urgent R-2013-13 letters, dated July 30, 2013 were sent overnight via Federal Express to customers. The letters identified the affected product, as well as the potential risk involved. Actions to be taken were provided for both hospital and sales representatives. Hospital representatives were asked to inspect their inventory, locate all devices from the list provided, and quarantine them immediately. The Inventory Return Certification Form should be completed and returned, regardless of whether any affected product is on hand or not. Contact the Smith & Nephew Returns Group at 800-343-5717 option 3) or send an e-mail to ProductRecovery@smith-nephew.com. They will provide instructions for returning affected product and receiving a replacement.

Device

Device Recall smith & nephew
  • Modèle / numéro de série
    50209581 50220887 50231401 50216929 50226220 50231932 50218285 50229266 50235063 50240019 50245683 50251109 50254562 50256942 50263784 50279382 50291593 50302984 50303418 50327069 50330377 50351345 50361381 50404796 50408768 50419699 50433964 50250837 50256854 50269580 5027766 50304642 50342002 50401593 50417254
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US, including the states of AL, AR, CA, FL, GA, ID, IL, KS, MA, MI, MO, NC, TN, TX, and AK; and, country of Japan.
  • Description du dispositif
    High Flow Irrigation Extender; Part Number 72201021. || Arthroscopic accessories are indicated for use in access of the joint capsule.
  • Manufacturer
    Smith & Nephew, Inc., Endoscopy Div.

Manufacturer

Smith & Nephew, Inc., Endoscopy Div.
  • Adresse du fabricant
    Smith & Nephew, Inc., Endoscopy Div., 130 Forbes Blvd, Mansfield MA 02048
  • Société-mère du fabricant (2017)
    Smith & Nephew plc
  • Source
    USFDA