Events

Rappel de Device Recall EGR (Endoscopic Gastrocnemius Release System

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
    61183
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1226-2012
  • Date de mise en oeuvre de l'événement
    2012-01-06
  • Date de publication de l'événement
    2012-03-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-01-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107479
  • 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
    Accessories,arthroscopic - Product Code NBH
  • Cause
    The firm received several complaints from customers reporting that the blade of the egr system may not retract back into the device following surgery. the firm attributes this problem to user error or improper surgical technique on the part of the physician.
  • Action
    The firm sent a 'A Medical Device Correction Notice' with an attached Acknowledgement and Return Form to all consignees on 1/6/2012 via FedEx and E-mail. The Correction Notice informs customers of the firm's receipt of several complaints regarding the Endoscopic Gastrocnemius Release (EGR) System and the problem with non-retraction of the blade back into the device during surgery. Although no adverse health consequences or patient injuries have been reported to date, the notice is being issued by the firm in order to reinforce the importance of following the additional clarification to the Surgical Technique Manual. According to the firm, this action should serve to reduce the possibility in which the blade may fail to retract into the device. Questions were directed to (609) 936-6832.

Device

Device Recall EGR (Endoscopic Gastrocnemius Release System
  • Modèle / numéro de série
    Model # EGR 157, Part No.31-0040 and Model #EGR 138, Part No. 31-0138.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution, including the states of: MI, CA, TX, VT, OK, OH, NC, MN, CT, CO, TN, NY, NJ, MO, FL, WA, AR, MT, VA, IL, PA, NE, GA, AZ, WI, OR, MD, LA, IA, AL, MA, ID, KY, UT, NV, IN and SC.
  • Description du dispositif
    Integra Endoscopic Gastrocnemius Release (EGR) System. The device consists of one (1) unit which is kitted within an instrumentation tray. The Integra EGR System includes a range of instruments for endoscopic approach to the Gastrocnemius Aponeurosis Recession. The cutting instrument features a retracting blade for cutting the gastrocnemius aponeurosis. Associated instruments include an elevator, a cannula, and a cannula obturator, which are all consumable instruments provided sterile. The EGR System is indicated for the treatment of posterior heel cord contracture (Equinus) in those patients who fail to respond to conservative management.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.