Events

Rappel de Device Recall Serrated Soft Tissue Shields

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 X Spine Systems 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
    68863
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2136-2014
  • Date de mise en oeuvre de l'événement
    2014-07-11
  • Date de publication de l'événement
    2014-08-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-08-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128882
  • 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
    Guide, surgical, instrument - Product Code FZX
  • Cause
    Revision b of the tissue shields of the device was 7 mm longer than the previous design.
  • Action
    X-Spine systems contacted both customers via telephone and instructed to return the affected product back to X-Spine. All product has been recovered. The distributors have already returned the recalled product. No product was utilized in any surgical procedure. Immediate Action Taken: X-spine inventory was reviewed and two pieces of each size were recovered from finished inventory. The X-spine sales person returned the product. The distributor has returned the remaining product. The devices were recovered prior to use in any surgical procedure. For further questions please call (937) 847-8410

Device

Device Recall Serrated Soft Tissue Shields
  • Modèle / numéro de série
    Part numbers X079-0096 and X079-0097 with Lot #12320
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution including the states of FL and MO.
  • Description du dispositif
    Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
  • Manufacturer
    X Spine Systems Inc

Manufacturer

X Spine Systems Inc
  • Adresse du fabricant
    X Spine Systems Inc, 452 Alexandersville Rd, Miamisburg OH 45342-3658
  • Société-mère du fabricant (2017)
    X-Spine Systems, Inc
  • Source
    USFDA