Events

Rappel de Device Recall 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
    73069
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0797-2016
  • Date de mise en oeuvre de l'événement
    2016-01-08
  • Date de publication de l'événement
    2016-02-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-11-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142988
  • 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
    Wrench - Product Code HXC
  • Cause
    There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization. in worst case, the unexpected drop in torque value may lead to the spinal construct loosening and requiring corrective surgical intervention.
  • Action
    Affected consignees were notified via an Urgent Medical Device Recall Notification letter, dated 1/8/16. The letter identified the affected device and stated the reason for the recall. The recalling firm requests customers to remove the affected devices from their inventory and cease further distribution or use. Customers whom the devices were further distributed to should be notified that the affected devices cannot be used and must be returned to Orthofix per the instructions provided. The attached Acknowledgement Form should be completed and returned. Customers can contact their local Orthofix representative or customer service for further information, replacements, or disposal instructions.

Device

Device Recall Firebird Spinal Fixation System
  • Modèle / numéro de série
    BS535418105, BS535419118, BS535420030,  BS535419124, BS562325021, BS535418158, BS535418038, BS535418138, BS535418012, BS535419006, BS535420039,  BS535418127,  BS549024010, BS535419141, BS535418081, BS535418111, BS535418117, BS535420041, BS535418144, BS535420081, BS535419151, BS562325006, BS546825008, BS535418002, BS535418013, BS535418131, BS535420006, BS535420010, BS535420026, BS535420047, BS556219012, BS556219026, BS535418109, BS535420082, BS557717009, and  BS562325023.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US, Spain, Italy, and Australia.
  • Description du dispositif
    Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) || Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).
  • 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