Events

Rappel de Device Recall Tibila Insert CK

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 Ortho Development Corporation.

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
    68898
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2257-2014
  • Date de mise en oeuvre de l'événement
    2014-07-11
  • Date de publication de l'événement
    2014-08-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-10-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128979
  • 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
    Ortho development is recalling various pivot bipolar cup, patella, ps tibial insert, uc tibila insert, and ck tibil insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.
  • Action
    Ortho Development notified all affected consignees/distributors of the recall via email on July 11, 2014 which included a list of the affected product (part numbers, lot numbers and quantities) under their control. An RMA number and return shipping label were also included with the email. Emails were followed up with phone calls to verify receipt of the notification.

Device

Device Recall Tibila Insert CK
  • Modèle / numéro de série
    CK Tibial Insert Sz 6 12mm Part 563-1612, Lot A135666
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.
  • Description du dispositif
    Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY || Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the femoral component where additional joint constraint is needed
  • Manufacturer
    Ortho Development Corporation

Manufacturer

Ortho Development Corporation
  • Adresse du fabricant
    Ortho Development Corporation, 12187 Business Park Dr, Draper UT 84020-8663
  • Société-mère du fabricant (2017)
    Ortho Development Corporation
  • Source
    USFDA