Integra Endoscopic Gastrocnemius Release (EGR) System. The device consists of one (1) unit which is kitted within an ins

FDA device recall Z-1226-2012 · posted 2012-03-19 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

Reason for recall

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 taken

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.

Root cause

Labeling mix-ups

Status

Terminated

Product code

NBH

Quantity affected

850 units

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.

Date initiated

2012-01-06

Date posted

2012-03-19

Date terminated

2014-01-23

Location

Plainsboro, NJ