Events

Rappel de OTTO BOCK Kenevo knee joints

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 Otto Bock Healthcare Product.

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
    79019
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0815-2018
  • Date de mise en oeuvre de l'événement
    2017-09-12
  • 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=161206
  • 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
    Joint, knee, external limb component - Product Code ISY
  • Cause
    Otto bock healthcare products gmbh has identified a design issue through extended durability testing where the pylon clamping mechanism has the potential to cause damage to the pylon. when used longer than 1.45 million cycles (which represents approximately 2.3 years of use of the knee joint under heavy usage conditions), and the pylon clamp is overtightened according to the labeled torque specification, and the patient weighs at most 125kg it may be remote that the pylon breaks, and causing the patient to fall. there have been no failures or complaints reported directly attributed to the failure mode collapsed pylon. in the us market and in canada, labeling requires a condition based service at three years. in the rest of the world, a mandatory two year service interval is specified. only the devices in distribution in the united states and canada are affected by this action.
  • Action
    On September 14, 2017 a letter was sent to all their consignees via 2nd day signature receipt required to customers instructing them to contact their patients and send in their devices for service within the first 2.3 years of use. The pylon clamp will be replaced at no charge. The pylon will also be inspected and replaced if necessary. The customer will be requested to complete a reply form indicating they have received the notice and intend to contact their patients to arrange for the requested service. Customer Service: (800) 328-3458  Option 1 Loaner Service: (800) 328-3458  Option 3, then Option 1

Device

OTTO BOCK Kenevo knee joints
  • Modèle / numéro de série
    Serial Numbers:  201520028, 201520027, 20150026, and 201530040.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    AK, AR, AZ, CA, CT, DC, GA, IL, IN, KY, LA, MD, MI, MN, NC, ND, NJ, MN, NY, OH, OK, OR, PA, PR, TX, VA, and WA AU, BE, DE, FR, GB, IT, KW, LU, NL, NO, AT, SA, SE, CH, ES, ZA, and HU
  • Description du dispositif
    OTTO BOCK Kenevo knee joints Model 3C60=ST
  • Manufacturer
    Otto Bock Healthcare Product

Manufacturer

Otto Bock Healthcare Product