Events

Rappel de Blackstone Medical Inc. Firebird Spinal Fixation System

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
    57199
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1674-2011
  • Date de mise en oeuvre de l'événement
    2010-10-22
  • Date de publication de l'événement
    2011-03-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-05-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95588
  • 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
    Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
  • Cause
    There is a possibility that certain multi-axial screws have spherical heads measuring less than the allowable tolerance.
  • Action
    Orthofix sent an URGENT: PRODUCT RECALL letter dated October 22, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their accounts immediately and advise them of the recall situation and have them return any affected inventory. For any questions customers were instructed to contact their Account Services Representative at 1-888-298-5700. For questions regarding this recall call 214-937-2061.

Device

Blackstone Medical Inc. Firebird Spinal Fixation System
  • Modèle / numéro de série
    Catalog #'s: 77-7630 and 77-8630.  510(k) Information: K081684 (Blackstone Medical Inc.). Lot #: R01. UPC's: M3327776301G and M3327786301H.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including AZ, NY, TX, MS, LA, FL, NC, and AR.
  • Description du dispositif
    BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Bone Screw, Self Tapping, Cannulated. BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Multi-Axial Screw, Self Tapping, Cannulated. || The Multi-Axial Screw is a pedicle screw which is inserted into the pedicle with the use of the Multi-Axial Screw Driver. The component is used within the Firebird Spinal Fixation System. The screw is cannulated and available modular (77-7630, pre-assembled with screw head) or non-modular (77-8630, without screw head). Product Code: NKB-Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease. Class II. || Intended for use when implanted over a guide wire for additional accuracy with reference to the pedicle.
  • Manufacturer
    Orthofix Inc

Manufacturer

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