Events

Rappel de Orthofix ISKD Limb Lengthener Sterile Rx Only

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 Orthofix, 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
    62804
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0895-2013
  • Date de mise en oeuvre de l'événement
    2012-08-06
  • Date de publication de l'événement
    2013-02-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-05-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111748
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Cause
    There is a possibility that the iskd limb lengthener may stop distracting post-operatively during treatment, which may result in premature bone consolidation (limb not achieving the desired length) leading to revision surgery to remove and/or replace the device.
  • Action
    Orthofix sent an Urgent Product Recall Notification letter dated August 6, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue distribution of devices, identify the affected and remove from their inventory, and returned to the firm. Credit will be issued upon receipt of the returned product. Customers were asked to take the actions listed in the enclosed Product Return Instructions immediately. Customers with questions should contact Orthofix Customers Service by telephone at 800-266-3349 or 214-937-2047. For questions regarding this recall call 214-937-2509.

Device

Orthofix ISKD Limb Lengthener Sterile Rx Only
  • Modèle / numéro de série
    All serial numbers of the following Catalog Numbers: F12-255-305, F12-345-395NS, T12-245-295, F12-255-305NS, F12-345-425, T12-255-305, F12-255-335, F12-345-425NS, T12-255-305NS, F12-255-335NS, T10-215-265, T12-255-335, F12-300-350, T10-255-305, T12-255-335NS, F12-300-350NS, T10-255-335, T12-300-350, F12-300-380, T10-300-350, T12-300-350NS, F12-300-380NS, T12-215-265, T12-300-380, F12-345-395, T12-215-265NS, and T12-300-380NS
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) Internationally to Australia, Hong Kong, Saudi Arabia, Korea, Turkey, Greece, Finland, South Africa, Spain, Singapore, Switzerland, Brazil, Germany, France, Japan, Netherlands, New Zealand, Israel, Canada and Mexico
  • Description du dispositif
    Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. || The ISKD is intended for limb lengthening of the tibia and femur.
  • Manufacturer
    Orthofix, Inc

Manufacturer

Orthofix, Inc
  • Adresse du fabricant
    Orthofix, Inc, 3451 Plano Pkwy, Lewisville TX 75056-9453
  • Société-mère du fabricant (2017)
    Orthofix International Nv
  • Source
    USFDA