Events

Rappel de Device Recall LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT

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..

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
    69759
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0591-2015
  • Date de mise en oeuvre de l'événement
    2014-11-04
  • Date de publication de l'événement
    2014-12-12
  • 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=131483
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Cause
    The stem taper on this device is undersized; the gauge point is not deep enough.
  • Action
    The firm, Smith & Nephew, Inc., sent an "Urgent-Product Recall 1st Notification-Urgent" letter dated 11/4/ 2014 to its customers via E-mail on 11/4/2014. International distributors were notified on 11/4/2014 by Email. Non-responding consignees will be contacted on 11/25/2014 by original method. The letter described the product, problem, and actions to be taken. The customers were instructed to inspect your inventory and locate any unused devices and immediately quarantine; complete and return the Inventory Return Certification Form via fax to: +1-901-566-7975, even if you do not have product to return; contact Smith & Nephew's Safety Affairs Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to obtain return authorization (RA) number; and return affected product to Smith & Nephew, Attn: Global Field Actions, 3303 E Holmes Road, Memphis, TN 38118. If you have any questions, please contact the Group Director, Quality Assurance +1-901-399-1970.

Device

Device Recall LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT
  • Modèle / numéro de série
    Lot Number 14EM23391
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: MI, MN, MO, OH, PA, IA, and TN; and Internationally to: SWITZERLAND; CANADA, COLOMBIA, GERMANY, Dubai, (UAE), THAILAND; SOUTH AFRICA, SOUTH KOREA; and SINGAPORE.
  • Description du dispositif
    LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis || Usage:orthopedic.
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • Adresse du fabricant
    Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
  • Société-mère du fabricant (2017)
    Smith & Nephew plc
  • Source
    USFDA