Events

Rappel de Device Recall Axle Interspinous Fusion System Torque Driver Handle

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 X Spine Systems 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
    59756
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0034-2012
  • Date de mise en oeuvre de l'événement
    2011-07-15
  • Date de publication de l'événement
    2011-10-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-03-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103598
  • 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
    General and plastic surgery - Product Code FZS
  • Cause
    The firm learned that the torque driver handles were not actuating at a proper torque. it was determined that the handles were speed determinant and could output a higher torque if the handles were turned at a very slow speed.
  • Action
    X-spine Systems, Inc. sent an URGENT DEVICE RECALL letter dated September 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their stock immediately to determine if they have any affected product. If so, customers were instructed once the set screw is tightened onto the locking plate, and resistance is detected in the handle, it will take less than 2 seconds to hear the handle "click." The "click" indicates the torque limit was reached. If further resistance is felt after 2 seconds, the surgeon should release the handle from tension, and try again. If the product was distributed further, they should contact their accounts, and advise them of this recall. The firm will send replacement handles. For any questions call (937) 847-8400, ext 115.

Device

Device Recall Axle Interspinous Fusion System Torque Driver Handle
  • Modèle / numéro de série
    Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including CA, CO, FL, IA, IN, LA, NY, PA, TN, TX and UT.
  • Description du dispositif
    Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 || The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
  • Manufacturer
    X Spine Systems Inc

Manufacturer

X Spine Systems Inc
  • Adresse du fabricant
    X Spine Systems Inc, 452 Alexandersville Rd, Miamisburg OH 45342-3658
  • Société-mère du fabricant (2017)
    X-Spine Systems, Inc
  • Source
    USFDA