Events

Rappel de Stryker TRIO/TRIO

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
    62663
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2235-2012
  • Date de mise en oeuvre de l'événement
    2012-04-25
  • Date de publication de l'événement
    2012-08-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-02-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111305
  • 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 - Product Code MNI
  • Cause
    The front cover of instructions for use (ifu) #noli135b03rev02 was improperly marked with a "sterile" logo in the lower right corner. the products these ifus were packed with are sold as "non-sterile" and require sterilization before use in surgery.
  • Action
    Stryker sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter to affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Customer Response Form was attached for customers to complete and return via fax to 201-760-8370. Contact the firm at 201-760-8298 for questions regarding this notice.

Device

Stryker TRIO/TRIO
  • Modèle / numéro de série
    Code information listed in the following format: Manufacturer Part Number/Prodcut Description/Corresponding IFU Part Number/Affected Lot #s are as follows:  48900445/Trio Standard Post Screw 5.5x55mm/#NOLI135B03Rev02/57281 and 57201  48900450/Trio Standard Post Screw 5.5x60mm/#NOLI135B03Rev02/57197   48900455/Trio Standard Post Screw 4.5x45mm/#NOLI135B03Rev02/57198  48900555/Trio Standard Post Screw 4.5x50mm/#NOLI135B03Rev02/56599  48900560/Trio Standard Post Screw 4.5x55mm/#NOLI135B03Rev02/57192
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed in Atlanta, Georgia.
  • Description du dispositif
    The Instructions For Use for the following: || Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW || Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW || Stryker TRIO+ 4.5 x 55 mm STANDARD POST SCREW || Stryker TRIO+ 5.5 x 45 mm STANDARD POST SCREW || Stryker TRIO+ 5.5 x 60 mm STANDARD POST SCREW || Manufactured by: STRYKER Spine SAS, Z.I. Marticot - 33610 - Cestas-France +33 (0)5.57.97.06.30 http://www.stryker.com || Distributed in the USA by: Stryker Spine, 2 Pearl Ct., Allendale, NJ 07401-1677 USA +1-201-750-8000. || The system is intended for posterior, non-cervical pedicle and non-pedicle pedicle fixation of the spine. It is indicated for: degenerative disc disease (DDD), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis kyphosis, lordosis, spinal tumor, pseudarthrosis, and failed previous fusion.
  • 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