Class 2 Device Recall Smith & Nephew

• Date Initiated by Firm: June 19, 2006
• Date Posted: July 13, 2006
• Recall Status: Terminated on January 10, 2008
• Recall Number: Z-1230-06
• Recall Event ID: 35766
• 510(K)Number: K031675
• Product Classification: Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
• Product: Dyonics Electroblade, 4.5 Full Radius, Valleylab Generator-Compatible Part Number: 7205961
• Code Information: Lot Numbers: Equal to or lower 50151697 Expanded Recall: Lot Numbers: 50173181, 50175084
• FEI Number: 3003604053
• 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: Sterility seal of the package tray may have gaps/voids compromising the sterility of the device.
• FDA Determined Cause: Other
• Action: Smith & Nephew notified consignees by Certified letter dated 6/19/06. Accounts are requested to return product. Smith & Nephew expanded the recall on 8/2/5/06 by letter to include addtional lot numbers.
• Quantity in Commerce: 445 boxes/Expanded 348 units
• Distribution: Nationwide Foreign: Smith & Nephew Canada, Germany, France, Istanbul
• 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 = GEI