Class 1 Device Recall Smith & Nephew

• Date Initiated by Firm: January 19, 2007
• Date Posted: March 29, 2007
• Recall Status: Terminated on January 18, 2008
• Recall Number: Z-0662-2007
• Recall Event ID: 37232
• 510(K)Number: K034012
• Product Classification: Probe, Radiofrequency Lesion - Product Code GXI
• Product: RF Denervation Probe, 5cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain. Part Number: 7210270
• Code Information: Lot Numbers: 602549,602550, 602846, 602847
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc. Endoscopy Division; 150 Minuteman Drive; Andover MA 01810-1031
• For Additional Information Contact: Jason Bilobram; 978-474-6332
• Manufacturer Reason for Recall: Product is non-sterile but labeled incorrectly as sterile.
• FDA Determined Cause: Other
• Action: Smith & Nephew notified accounts by letter sent via Federal Express January 19, 2007
• Quantity in Commerce: 56 units
• Distribution: Worldwide, including USA, Denmark, France, UK, Germany, Korea, Switzerland, Italy, Spain, and South Africa.
• 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