Events

Rappel de Device Recall Sequoia Spinal System Surgical Kits

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 Abbott Spine.

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
    46888
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1479-2008
  • Date de mise en oeuvre de l'événement
    2008-02-13
  • Date de publication de l'événement
    2008-07-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-07-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68389
  • 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
    Pedicle screw spinal system - Product Code NKB
  • Cause
    Screw head dissociation: the polyaxial screw head may dissociate from screw shaft during surgery. also, the polyaxial screw driver is experiencing difficulty (broken/bent driver shafts, difficulty attaching screws to the driver and jamming of the collet.).
  • Action
    The recalling firm notified sales reps regarding the recall by phone on 02/13/08. The sales reps were instructed to discontinue kit use in surgeries and to return inventory. Surgeons who had used the Sequoia System in surgery were notified of the recall via letter on 02/20/08. Surgeons were asked to monitor for post-operative dissociation in implanted patients and to notify Abbott Spine sales reps if any incidences occur.

Device

Device Recall Sequoia Spinal System Surgical Kits
  • Modèle / numéro de série
    Part Numbers: 3300-0001-PL and 3300-0002-PL.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including states of AR, AZ, CA, CT, CO, FL, IL, MD, MI, MN, NC, OH, OK, OR, PA, TX, VA and WI.
  • Description du dispositif
    Sequoia Spinal System Surgical Kits; Pedicle screw spinal system; Non-sterile (kits intended to be sterilized prior to use); Rx Only; || The Sequoia Spinal System is designed to aid in the surgical correction of several types of spinal conditions. The product is a system of smaller devices used to provide stabilization during the development of a solid fusion mass.
  • Manufacturer
    Abbott Spine

Manufacturer

Abbott Spine
  • Adresse du fabricant
    Abbott Spine, 12708 Riata Vista Cir # B-100, Austin TX 78727-7167
  • Source
    USFDA