—#107479

Product

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.

FDA product code: NBH — Accessories, Arthroscopic
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Model # EGR 157, Part No.31-0040 and Model #EGR 138, Part No. 31-0138.

Why it was recalled

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.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2012-01-06
Posted by FDA: 2012-03-19
Terminated: 2014-01-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107479. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.