Events

Rappel de Otto Bock Compact prosthetic knee joint

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 Bock,Otto,Orthopedic Ind,Inc.

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
    36256
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0363-2007
  • Date de mise en oeuvre de l'événement
    2006-08-10
  • Date de publication de l'événement
    2007-01-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-11-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48263
  • 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
    external leg prosthesis - Product Code KFX
  • Cause
    A correction of the otto bock compact prosthetic knee joint, material numbers 3c93 and 3c85, is being conducted. a limited number of compacts have a defective solder connection between the contact wires and battery terminals. if exposed to strong vibrations these compact knee joints have an increased probability of malfunction and a resultant risk to the compact wearer.
  • Action
    An Urgent Correction Notice, dated August 11, 2006, was sent to customers who purchased the Compact Prosthetic knee joint. The letter identifies affected units, asks for all in stock devices to be returned to Otto Bock, and for patients fitted with an affected device, a loaner knee will be provided as a temporary replacement while their device is serviced.

Device

Otto Bock Compact prosthetic knee joint
  • Modèle / numéro de série
    Material number 3C85, serial numbers: 200547006, 200547007, 200547008, 200547009, 200547034, 200547035, 200547036, 200547037, 200547038, 200547039, 200548022, 200548023, 200548037, 200548038, 200548039, 200548040, 200548041, 200548042, 200604015, 200604016, 200604017, 200604021, 200604022, 200604024, 200604064, 200605002, 200613003.   Material number 3C95, serial numbers: 200531057, 200531058, 200531059, 200531060, 200547003, 200547004, 200547005, 200547024, 200547049, 200547050, 200547051, 200547052, 200547053, 200547054, 200547055, 200547056, 200547057, 200548007, 200548008, 200548009, 200548010, 200548011, 200548012, 200548013, 200548014, 200548015, 200548016, 200548017, 200548018, 200548019, 200548020, 200548034, 200548035, 200548036, 200548044, 200548045, 200548046, 200548047, 200548048, 200548049, 200548051, 200548052, 200548053, 200548054, 200548055, 200548056, 200548058, 200548059, 200548060, 200548061, 200548062, 200548063, 200548064, 200548065, 200548067, 200548068, 200604001, 200604002, 200604003, 200604004, 200604005, 200604006, 200604007, 200604008, 200604009, 200604010, 200604012, 200604013, 200604014, 200604026, 200604027, 200604028, 200604029, 200604030, 200604032, 200604033, 200604034, 200604035, 200604036, 200604038, 200604039, 200604040, 200604041, 200604042, 200604043, 200604044, 200604045, 200604053, 200604054, 200604055, 200604056, 200604057, 200604058, 200604059, 200604062, 200604063, 200605003, 200605004, 200605005, 200605006, 200605008, 200605009, 200605010, 200605018, 200605019, 200605020, 200605021, 200605022, 200605023, 200605054, 200605055, 200605057, 200605058, 200605059, 200605060, 200605061, 200612015, 200612016, 200612017, 200612018, 200612019, 200612020, 200612021, 200612024, 200612029, 200612045, 200612047, 200612050, 200612051, 200612052, 200612053, 200612054, 200612056, 200613034, 200613035, 200613038, 200613039, 200613041, 200613042, 200613043, 200613044, 200613045, 200613054, 200613055, 200613056, 200613057, 200613061, 200613062, 200613063.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide.
  • Description du dispositif
    Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85, to be used exclusively for the exoprosthetic fitting of amputations of the lower limb. Microprocessor-controlled prosthetic knee joint used by lower extremity amputees.
  • Manufacturer
    Bock,Otto,Orthopedic Ind,Inc

Manufacturer

Bock,Otto,Orthopedic Ind,Inc
  • Adresse du fabricant
    Bock,Otto,Orthopedic Ind,Inc, Two Carlson Parkway North, Suite 100, Minneapolis MN 55447
  • Source
    USFDA