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U.S. Department of Health and Human Services

Class 2 Device Recall ENDOPATHETS and ETSFlex Endoscopic Linear Cutter Reload

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  Class 2 Device Recall ENDOPATHETS and ETSFlex Endoscopic Linear Cutter Reload see related information
Date Initiated by Firm April 24, 2008
Date Posted August 25, 2008
Recall Status1 Terminated 3 on April 03, 2012
Recall Number Z-2163-2008
Recall Event ID 48604
510(K)Number K020779  
Product Classification Surgical Cutter, Implantable Staple - Product Code FZT
Product ENDOPATH¿ETS and ETS-Flex Endoscopic Linear Cutter Reload; TR35W.

Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
Code Information Batch #s: D4G80E, D4G85W, D4G903, D4G94L, D4GA32, D4GD36, D4GE66, D4GH0T, D4GJ2K, D4GK3Y, D4GK9L, D4GM52, D4GM7U, D4GN6E, D4GP0J, D4GP4R, D4GP72, D4GR0X, D4GT2T, D4GV6T, D4GV87, D4GW38, D4GW9W, D4H070, D4H18C, D4H22G, D4H44D, D4H46J, D4H48L, D4H49L, D4H51F, D4H60R, D4H70P, D4H72W, D4H77M, D4H86J, D4H903, D4H930, D4HA5E, D4HC0M, D4HC72, D4HE2N, D4HG0T, D4HG35, D4HG6F, D4HG9G, D4HH5V, D4HH9D, D4HJ8K, D4HL4G, D4HM5L, D4HN53, D4HP27, D4HP58, D4HP9X, D4HR68, D4HT58, D4HU52, D4HW1L, D4HW24, D4HW7N, D4HX45, D4HX8P, D4HY1D, D4HY6U, D4HZ5K, D4J03R, D4J08F, D4J13C, D4J187, D4G51J, D4G56F, D4G69L, D4G725
Recalling Firm/
Manufacturer		 Ethicon Endo-Surgery Inc
4545 Creek Rd
Cincinnati OH 45242-2803
For Additional Information Contact Anthony Brewer
513-337-7000
Manufacturer Reason
for Recall		 The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
FDA Determined
Cause 2		 Other
Action Firm issued an Urgent: Device Recall notification instructing the user to not use products from these lot numbers. Examine their inventory immediately to determine if they have affected product on hand and remove them from inventory. Complete the Business Reply Form and fax it back. To return affected product, copy the BRF, place in box with your product, and affix the pre-printed UPS shipping label.
Quantity in Commerce 14,784 pieces
Distribution Worldwide Distribution --- including USA and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CAYMAN ISLANDS, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, EGYPT, EL SALVADOR, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEBANON, MEXICO, PAKISTAN, POLAND, PORTUGAL, PUERTO RICO, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM & VENEZULA.
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 = FZT and Original Applicant = ETHICON ENDO-SURGERY, INC.
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