Events

Rappel de 3DKnee e Tibial Insert

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 Encore Medical, Lp.

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
    62801
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2302-2012
  • Date de mise en oeuvre de l'événement
    2012-08-09
  • Date de publication de l'événement
    2012-08-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-01-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111744
  • 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 + additive/metal/polymer - Product Code OIY
  • Cause
    The firm is recalling one lot of 392-09-706, 3dknee e+ tibial insert, 9 mm, size 6, right. the shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired.
  • Action
    DJO Global sent an Urgent Field Safety Notice dated August 9, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the Notice to all those who need to be aware within their organization or to any organization where the potentially affected product has been transferred. Customers were instructed to contact the firm to place a replacement order and receive an RMA number. For questions customers were asked to call 512-834-6255. For questions regarding this recall call 512-832-9500.

Device

3DKnee e Tibial Insert
  • Modèle / numéro de série
    Model Number 392-09-706, Lot Number 59602519
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution including Venezuela.
  • Description du dispositif
    3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. || The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This insert is to be used along with the other components that comprise the 3DKnee System.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

Encore Medical, Lp
  • Adresse du fabricant
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA