Events

Rappel de Device Recall TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws

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 Integra LifeSciences Corp..

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
    74114
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1965-2016
  • Date de mise en oeuvre de l'événement
    2016-05-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146323
  • 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
    Plate, fixation, bone - Product Code HRS
  • Cause
    As a result of an internal investigation of a non-conformance it has been determined: 1) depth gauges from lot up15h2 exceed the overall length specification requirements. 2) depth gauges from prior lot numbers manufactured before integra acquired the product line reflect an incorrect number for the first mm depth marking on the gauge. the number should be 4, it is 6. 3) the space / holder.
  • Action
    The firm, Integra Lifesciences, sent an "Urgent: Voluntary Medical Device Recall" letter dated 5/10/16 to affected consignees/customers via traceable courier service on 5/10/16. The letter describes the product, problem and actions to be taken. The customers were instructed to stop using and distributing product immediately; complete and return the Recall Acknowledgement and Return Form via fax to 1-609-275-9445 or email to FCA2@integralife.com, even if you do not have any of the product. Should you have any questions, please contact Customer Service at 1-866-854-8300.

Device

Device Recall TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws
  • Modèle / numéro de série
    Lot UP15H2, Lot UP09D3, Lot UP07E2
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution to states of: CO, FL, IL, MI, NJ, NY, SC, TX, and VA.
  • Description du dispositif
    TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws || The FS2030 Depth Gauge is used by the physician to determine the correct screw length when implanting a 2.0 or 2.5mm TS Series screw for the Ti6 Internal Fixation System.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.