Events

Rappel de Device Recall Integra HalluFix cannulated screw driver and cannulated screwdriver tip

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 Integra LifeSciences Corp..

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
    65503
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1685-2013
  • Date de mise en oeuvre de l'événement
    2013-02-01
  • Date de publication de l'événement
    2013-07-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119360
  • 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
    Screwdriver, surgical - Product Code LRZ
  • Cause
    The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery.
  • Action
    The firm sent recall notification letters to all consignees via traceable email or traceable fax on 02/01/13. The firm requested that the consignees fill out and return the Recall Acknowledgement and Return Form.

Device

Device Recall Integra HalluFix cannulated screw driver and cannulated screwdriver tip
  • Modèle / numéro de série
    The following lots of the cannulated screw driver (model number P/N 129733ND) were affected: D2ZG, D32L, D3HV, D3PG and E0U3.   The following lots of the cannulated screwdriver tip (model number P/N 129735ND) were affected: D2ZQ and D3EC.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, PA, RI, SC, TN, TX, UT, VA, and WA and the countries of Canada, Austria, Belgium, Switzerland, Czech Republic, Germany, Denmark, Spain, Finland, France, Ireland, Israel, Italy, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, United Arab Republic, United Kingdom, and South Africa.
  • Description du dispositif
    Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). || Indicated for use in fixation of fractures, osteotomies and arthrodesis of the first metatarso-phalangeal joint.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.