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U.S. Department of Health and Human Services

Class 2 Device Recall FlexTray " Procedure Delivery System Cholecystectomy Tray

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  Class 2 Device Recall FlexTray " Procedure Delivery System Cholecystectomy Tray see related information
Date Initiated by Firm April 12, 2013
Date Posted July 19, 2013
Recall Status1 Terminated 3 on May 01, 2014
Recall Number Z-1776-2013
Recall Event ID 65141
510(K)Number K864102  K830503  K812291  
Product Classification Applier, surgical, clip - Product Code GDO
Product LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Trays), 10mm M/L

Product Usage:
The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instrument designed to provide a means of ligation through ENDOPATH¿ surgical trocars. The instrument delivers 20 titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360¿ in either direction. The rotating knob is located to allow for a one-handed technique.
Code Information FNC40XL, 41, 2017-09 to 2018-01; FNC41XL, 41, 2016-12 to 2018-02; FNC41XLD, 41, 2016-12 to 2018-02; FNC42XL, 41, 2016-12 to 2018-02; FNC43XL, 41, 2016-12 to 2018-02; FNC43XLD, 41, 2017-02 to 2018-02; KBC17XL, 41, 2016-12 to 2018-2; KNC03XL, 41, 2017-02 to 2017-06; KNC03XL, 42, 2017-09 to 2017-10; KNC03XL, 43, 2017-10; KNC07XL, 41, 2017-01 to 017-05; KNC07XL, 42, 2017-09 to 2017-10; KNC09XL, 41, 2016-12 to 2018-03; KNC19XL, 41, 2017-02; KNC60XL, 41, 2016-2 2018-02; KNC61XL, 41, 2016-12 to 2018-02; TNC20XL, 41, 2017-02 to 2017-03; TNC20XL, 43, 2017-10; TNC36XL, 41, 2017-01 to 2018-03; TNC49XL, 41, 2016-12 to 2018-02; TNC69XL, 41, 2016-12 to 2017-05; TNC69XL, 43, 2017-10 to 2018-1; XCB51S, 41, 2017-01; XCB51S, 42, 2017-09 to 2017-10; XCB52S, 41, 2016-12 to 2018-02; XCB55S, 41, 2017-07; XCB55S, 42, 2017-09 to 2017-10; XCB57S, 41, 2016-12 to 2018-01; XCC50S, 41, 2016-12 to 2018-02; XCC51S, 41, 2016-12 to 2018-02; XCC53S, 41, 2016-12 to 2018-02; XCD50S, 41, 2016-12 to 2018-02; XCD51S, 41, 2016-12 to 2018-02; XCD52S, 41, 2016-12 to 2018-01; KNC35XL, 42, 2017-09 to 2017-10; XBB48B, 41, 2016-07 to 2017-01; XBB48B, 42, 2017-02 and XBB79S, 41, 2017-05 to 2017-06.
Recalling Firm/
Manufacturer		 Ethicon Endo-Surgery Inc
4545 Creek Rd
Cincinnati OH 45242-2803
For Additional Information Contact Thomas A. Morris
513-337-3419
Manufacturer Reason
for Recall		 Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure
FDA Determined
Cause 2		 Under Investigation by firm
Action Ethicon sent an Urgent : Medical Device Recall letter dated April 30, 2013 to all primary and secondary consignees via overnight UPS to allow tracking of the receipt. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory immediately and return affected products for credit. This credit is intended to facilitate replacement purchase. For questions contact your local representative or call Ethicon Customer Support Center at 1-877-384-4266 option 6.
Quantity in Commerce 49,357
Distribution Worldwide Distribution - USA Nationwide to all fifty (50) states, and internationally including the following countries: ARGENTINA, ARGENTINA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, ECUADOR, EGYPT, EL SALVADOR, GREECE, HONDURAS, INDIA, INDONESIA, ISRAEL, JAMAICA, JAPAN, JORDAN, KOREA, REPUBLIC OF, KUWAIT, LEBANON, MEXICO, NETHERLANDS ANTILLES, NICARAGUA, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, PUERTO RICO, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, TAIWAN, PROVINCE OF CHINA, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA and YEMEN.
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 = GDO and Original Applicant = ETHICON, INC.
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