Class 2 Device Recall Endopath

• Date Initiated by Firm: November 21, 2004
• Date Posted: February 01, 2005
• Recall Status: Terminated on October 29, 2008
• Recall Number: Z-0462-05
• Recall Event ID: 30516
• 510(K)Number: K020779
• Product Classification: Staple, Implantable - Product Code GDW
• Product: Endopath EZ45 No Knife Linear Stapler (NK45G).
• Code Information: NK45G: lots: V40Z1C, V41M2N, V42H3V, V4Z42W, V4ZU1N.
• Recalling Firm/ Manufacturer: Ethicon Endo-Surgery; 4545 Creek Rd; Cincinnati OH 45242-2803
• For Additional Information Contact: Dennis Hahn; 513-337-3134
• Manufacturer Reason for Recall: The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue.
• FDA Determined Cause: Other
• Action: The firm sent letters, dated 11/21/04, to all consignees.
• Quantity in Commerce: 199 devices.
• Distribution: The product was distributed to hospitals and distributors throughout the United States and to foreign customers located in Korea, China, Republic of Singapore, Argentina, Italy, New Zealand, Austria, Canada, Australia, Brazil, United Arab Emirate, Thailand, Czech Republic, Sweden, Switzerland, Greece, Russia, India, Portugal, Israel, Poland, Hungary, and Uruguay.
• 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 = GDW