Events

Rappel de REFLEX HYBRID ANTERIOR CERVICAL PLATE 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 Stryker 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
    49441
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0217-2009
  • Date de mise en oeuvre de l'événement
    2008-08-18
  • Date de publication de l'événement
    2008-11-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-06-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73332
  • 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
    Appliance, fixation, spinal intervertebral body. - Product Code KWQ
  • Cause
    The reflex hybrid 4.0 x 14 mm variable, self tapping bone screw, lot nsz, was determined to have been anodized with the incorrect color for that screw.
  • Action
    An URGENT Product Recall Letter and a Stryker Spine Accountability Form were sent via FedEx with return receipt on August 18, 2008 to Stryker Branches and Hospital OR Supervisors. Letters notified branches of the recall and requested that they immediately identify and quarantine affected product and notify hospital locations that received shipment of product within 72 hours prior to identification of the problem. Letters sent to Hospital OR Supervisors described the problem and requested that all inventory locations be checked for affected product. If recalled product is found, Stryker Spine Representatives must be contacted to retrieve the recalled product from the facility. The Stryker Spine Accountability Form must be completed and returned via fax, 201-760-8269 to Stryker Spine. Contact Stryker Spine Clinical and Regulatory Affairs at 201-760-8150 or 201-760-8069 for questions or additional information.

Device

REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM
  • Modèle / numéro de série
    Lot code: NSZ.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    Reflex Hybrid 4.0 x 14 mm Variable, Self-Tapping Bone Screw (Non- sterile). || Manufactured by Stryker Spine SAS, Cestas, France. Distributed in USA by Howmedica Osteonics, Mahwah, NJ. || The bone screw (Reference # 48694014) is a 04.0 x 14mm used to attach the Reflex Hybrid Anterior Cervical Plate (ACP) to the anterior surface of the spine. The intended use of the system is as an aid in cervical spinal fusion through unilateral fixation.
  • Manufacturer
    Stryker Spine

Manufacturer

Stryker Spine
  • Adresse du fabricant
    Stryker Spine, 2 Pearl Ct, Allendale NJ 07401-1611
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA