Events

Rappel de Total Knee

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 Ossur H / F.

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
    53127
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0965-2012
  • Date de mise en oeuvre de l'événement
    2009-08-10
  • Date de publication de l'événement
    2012-02-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84735
  • 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
    Some units of the total knee junior produced between november 25th, 2008 and through april, 2009 contain balancing units that may fail under extreme use over a long period. the fault is noncritical and no incidents or injuries resulting from this situation have been reported to ossur at this stage. over long term use (estimated to be in the four to six year range) the prosthetic device may fail a.
  • Action
    Ossur sent a Safety Notice dated August 10, 2009 by mailed to all affected consignees. Ossur informed consignees of the above mentioned public reason for recall and asked consignees to take the following action: Identify the users of each of the Total Knee Junior model devices listed above and check inventory and isolate any recalled devices on hand but have not fitted on users. The letter states that Sue Fitzgerald from customer service will be contacting consignees in the next few days to coordinate replacement of the affected devices. For question call 1-(800) 219-2150, Ext: 4109. In addition, Ossur website: www.ossur.com we will be posting updates as appropriate.

Device

Total Knee
  • Modèle / numéro de série
    Serial Numbers: 8573, 8574, 8575, 8577, 8578, 8580, 8581, 8582, 8583, 8584, 8585, 8586, 8587, 8588, 8589, 8599, 8600, 8602, 8603, 8604, 8605, 8606, 8609, 8610, 8611, 8613, 8616, 8620, 8621, 8622, 8624, 8628, 8629, 8630, 8631, 8632, 8633, 8634, 8635, 8636, 8638, 8639, 8640, 8642, 8643, 8644, 8645, 8646, 8666, 8670, 8671, 8672, 8673, 8674, 8675, 8678, 8679, 8680, 8682, 8684, 8685, 8687, 8688, 8691, 8692, 8693, 8694, 8695, 8696, 8697, 8698, 8699, 8701, 8715, 8716, 8717, 8719, 8720, 8722, 8723, 8725, 8739, 8755, 8756, 8757, 8758, 8759, 8760, 8761, 8784, 8787.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) in the state of: AL, AR, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, and WV and the countries of: Australia, Canada, China, France, Germany, Hong Kong, Israel, Japan, Malaysia, Netherlands, New Zealand, Portugal, Puerto Rico, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, United Kingdom and United States.
  • Description du dispositif
    Total Knee Junior Model Number 1100 || Product Usage: || The Total Knee¿ Junior is an external polycentric prosthetic knee with a geometric locking system.
  • Manufacturer
    Ossur H / F

Manufacturer

Ossur H / F
  • Adresse du fabricant
    Ossur H / F, Grjothals 5, Reykjavik Iceland
  • Société-mère du fabricant (2017)
    Össur hf
  • Source
    USFDA