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U.S. Department of Health and Human Services

Class 2 Device Recall Endopath

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  Class 2 Device Recall Endopath see related information
Date Initiated by Firm November 21, 2004
Date Posted February 01, 2005
Recall Status1 Terminated 3 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/
Ethicon Endo-Surgery
4545 Creek Rd
Cincinnati OH 45242-2803
For Additional Information Contact Dennis Hahn
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 2
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 and Original Applicant = ETHICON ENDO-SURGERY, INC.