Events

Rappel de Device Recall Knee joint replacement

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 United Orthopedic 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
    79321
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1128-2018
  • Date de mise en oeuvre de l'événement
    2017-11-24
  • 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=161889
  • 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
    Uoc received a customer compliant report from our distributor on october 31, 2017 which stated that contents of the package do not match the product labeling.
  • Action
    Urgent Field safety notice was distributed to customers on November 24, 2017 via e-mail. The letter identified the affected product, problem and actions to be taken. For further questions, please call (949) 328-3366.

Device

Device Recall Knee joint replacement
  • Modèle / numéro de série
    Lot number 17B621AX
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US Distribution and to the countries of: UK, Iran, Greece, Pakistan, Switzerland, France, China, Taiwan, Italy, Korea and South Africa.
  • Description du dispositif
    U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, || 11mm Thick Catalogue number 2303-3032 || The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery.
  • Manufacturer
    United Orthopedic Corporation

Manufacturer

United Orthopedic Corporation
  • Adresse du fabricant
    United Orthopedic Corporation, No. 57 Park Avenue 2, Science Park, Hsinchu Taiwan
  • Société-mère du fabricant (2017)
    United Orthopedic Corp.
  • Source
    USFDA