Events

Recall of Device Recall EGR (Endoscopic Gastrocnemius Release System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integra LifeSciences Corp..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61183
  • Event Risk Class
    Class 2
  • Event Number
    Z-1226-2012
  • Event Initiated Date
    2012-01-06
  • Event Date Posted
    2012-03-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107479
  • Notes / Alerts
    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.
  • Extra notes in the data
    Accessories,arthroscopic - Product Code NBH
  • Reason
    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
  • Model / Serial
    Model # EGR 157, Part No.31-0040 and Model #EGR 138, Part No. 31-0138.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    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.