Events

Rappel de Device Recall Streamline

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 PIONEER SURGICAL TECHNOLOGY, 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
    69036
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2616-2014
  • Date de mise en oeuvre de l'événement
    2013-06-14
  • Date de publication de l'événement
    2014-09-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-09-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129377
  • 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
    The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.
  • Action
    Pioneer Surgical sent a Product Field Action letter on July 7, 2013, to all affected customers. The letter described the affected product and issue, and provided instructions for return of the recalled product. All 9 affected instruments were returned to Pioneer Surgical, reconditioned and sent back to the field. Customers with questions were instructed to call 906-226-4489. For questions regarding this recall call 906-226-4812.

Device

Device Recall Streamline
  • Modèle / numéro de série
    Lot number: 148062, 148440
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including TX, CA, IL, and FL.
  • Description du dispositif
    Streamline MIS Spinal Fixation System Fixed Rod Holder || NON STERILE, Rx only || The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (ODD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and /or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Streamline MIS instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
  • Manufacturer
    PIONEER SURGICAL TECHNOLOGY, INC.

Manufacturer

PIONEER SURGICAL TECHNOLOGY, INC.
  • Adresse du fabricant
    PIONEER SURGICAL TECHNOLOGY, INC., 375 River Park Cir, Marquette MI 49855-1781
  • Société-mère du fabricant (2017)
    RTI Surgical Inc
  • Source
    USFDA