Events

Rappel de Integra Ruggles Surgical Instrument ACF Distraction 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
    50112
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0854-2009
  • Date de mise en oeuvre de l'événement
    2008-10-22
  • Date de publication de l'événement
    2009-01-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-07-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74754
  • 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
    Orthopedic Manual Surgical Instrument - Product Code LXH
  • Cause
    A packaging error had occurred where 16 mm screws were packaged and labeled as 12 mm screws and vice versa.
  • Action
    Urgent: Product Recall Notification letters were sent via Fed Ex on October 22, 2008. The letter asked customers to quarantine any of the affected stock on hand and contact their local Integra Sales Representative for further assistance and for arrangement of product returns. Customers were to fill out the attached "Recall Acknowledgement and Return Form" indicating whether or not they possess any of the product identified in the letter. Additional questions can be directed to Christin Roach at 609-936-5413. A Urgent: Product Recall Second Notification dated 1/5/2009 was sent to customers providing them with additional information on the packaging error and included immediate and/or product used during surgery. This notification also requested that all surgeons be notified who were or may have been provided with any of the screws affected by this recall.

Device

Integra Ruggles Surgical Instrument ACF Distraction Screws
  • Modèle / numéro de série
    lot code 326081; and lot code 327081.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Integra Ruggles Surgical Instrument ACF Distraction Screws || Sterile, Rx only || Catalog number R6357A (12 mm), Catalog number R6397A (16 mm), || Integra LifeSciences Corp., 311 Enterprise Drive, Plainsboro, NJ 08536
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.