Class 2 Device Recall NeuroTherm

• Date Initiated by Firm: July 28, 2008
• Date Posted: January 13, 2009
• Recall Status: Terminated on September 24, 2009
• Recall Number: Z-0838-2009
• Recall Event ID: 50136
• 510(K)Number: K011387
• Product Classification: Radiofrequency lesion probe - Product Code GXI
• Product: NeuroTherm Simplicity III RF Electrode Model Number: RFDE-SI The lesioning of neural tissue.
• Code Information: Lot numbers: 080630- 1 B and 080630- 1 C Exp. June 2011
• FEI Number: 3002953813
• Recalling Firm/ Manufacturer: Neurotherm, Inc.; 2 De Bush Ave Unit A2; Middleton MA 01949-1679
• For Additional Information Contact: SAME; 978-777-3916
• Manufacturer Reason for Recall: Distal tip may detach from the probe
• FDA Determined Cause: Labeling design
• Action: NeuroTherrn sales representatives were notified telephonically or through e-mail. End users were notified through visits by NeuroTherm sales representatives on 7/28/08 and 8/15/08. For questions, please contact NeuroTherm, Inc. at 1-978-777-3916.
• Quantity in Commerce: 71 units
• Distribution: CO, FL, IL, OH, TN, TX , VA, and WY Foreign: Australia, China, and UK,
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GXI