Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ENDOPATHETS Endoscopic Linear Cutter

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall ENDOPATHETS Endoscopic Linear Cuttersee related information
Date Initiated by FirmApril 24, 2008
Date PostedAugust 25, 2008
Recall Status1 Terminated 3 on April 03, 2012
Recall NumberZ-2162-2008
Recall Event ID 48604
510(K)NumberK020779 
Product Classification Surgical Cutter - Product Code FZT
ProductENDOPATHETS Endoscopic Linear Cutter, TSW35. Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
Code Information Batch #s: D4G80V, D4G97P, D4G97R, D4GA09, D4GC96, D4GC97, D4GF6G, D4GH13, D4GH5J, D4GJ58, D4GK8C, D4GL2R, D4GN4E, D4GN99, D4GR13, D4GT54, D4GT6V, D4GT93, D4GT9Z, D4GV02, D4GV03, D4H03D, D4H03F, D4H042, D4H052, D4H053, D4H090, D4H091, D4H092, D4H441, D4H442, D4H50M, D4H58Z, D4H68R, D4H68T, D4H69Z, D4H99F, D4H99G, D4HC0R, D4HC1C, D4HE3E, D4HF3M, D4HG1D, D4HG1E, D4HH26, D4HJ3W, D4HJ3X, D4HK4P, D4HL73, D4HM13, D4HM15, D4HP2L, D4HP2M, D4HP6G, D4HP6J, D4HR98, D4HR9A, D4HV3A, D4HW7Y, D4HX1D, D4HY6J, D4HY98, D4HZ1M, D4HZ1N, D4J09J, D4J17L
Recalling Firm/
Manufacturer		 Ethicon Endo-Surgery Inc
4545 Creek Rd
Cincinnati OH 45242-2803
For Additional Information ContactAnthony 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
ActionFirm 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 Commerce10,734 pieces
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = FZT
-
-