Recall Z-1226-2012 ยท NBH Accessories, Arthroscopic
Integra LifeSciences Corp.
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,
| Date | Mar 19, 2012 (initiated Jan 6, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Labeling mix-ups |
| 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 Su |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.