Class 2 Device Recall Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil

• Date Initiated by Firm: September 04, 2007
• Date Posted: November 07, 2007
• Recall Status: Terminated on July 14, 2009
• Recall Number: Z-0114-2008
• Recall Event ID: 39409
• 510(K)Number: K930511
• Product Classification: electrosurgical pencil - Product Code GEI
• Product: Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil, sterile, Manufactured at Warsaw, Indiana; REF (P/N) 9560575.
• Code Information: All lots.
• FEI Number: 1824199
• Recalling Firm/ Manufacturer: Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK; 2500 Silveus Crossing; Warsaw IN 46582-8598
• For Additional Information Contact: 800-876-3133 Ext. 6333
• Manufacturer Reason for Recall: Packaging weakness may compromise sterility and instructions for use are inadequate.
• FDA Determined Cause: Package design/selection
• Action: Consignees were notified via letter dated September 4, 2007 to cease using the product and to contact the firm for instructions on how to return the product.
• Quantity in Commerce: 22,632
• Distribution: Worldwide, including USA, Hong Kong, India, Mexico, Netherlands, Qatar, Saudi Arabia and South Korea.
• 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