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U.S. Department of Health and Human Services

Class 1 Device Recall PROXIMATE and Transtar

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 Class 1 Recall
PROXIMATE and Transtar
see related information
Date Posted October 13, 2012
Recall Status1 Terminated on July 12, 2013
Recall Number Z-0057-2013
Recall Event ID 62879
Premarket Notification
510(K) Numbers
K030411  K030925  K051301  K991030 
Product Classification Staple, Implantable - Product Code GDW
Product Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The PROXIMATE HCS Hemorrhoidal Circular Staplers, (PPH01 and PPH03), and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculo mucosal tissue. The TRANSTARTM CIRCULAR STAPLER, (STR10), and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.
Code Information PPH01: 68 lots; 19,030 pieces; Expiration date April 2016 -June 2017; PPH03: 494 lots; 144,963 pieces; Expiration date March 2016 - June 2017; STR10: 3 lots; 432 pieces; Expiration date Sept 2016 - Oct 2016
Recalling Firm/
Manufacturer
Ethicon Endo-Surgery Inc
4545 Creek Rd
Cincinnati, Ohio 45242-2803
For Additional Information Contact Thomas A. Morris
513-337-7000
Manufacturer Reason
for Recall
Ethicon Endo-Surgery initiated this voluntary global recall for specific production lots of PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories 33mm (PPH01 and PPH03) and Transtar¿ Circular Stapler Procedure Set (STR10) due to difficulty firing the device which may result in incomplete firing stroke that may result in an incomplete staple formation.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control
Action Ethicon Endo-Surgery sent an Urgent Device Recall letter dated August 3, 2012 via overnight, Federal Express UPS to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory immediately, discontinue use, quarantine the material and return per the instructions provided. Customers were advised to complete the Business Reply Form (BRF) and fax it to Stericycle at 1-888-628-0733 within 3 business days, even if you do not have affected product. The letter states that Ethicon Endo-Surgery will issue credit for recalled products returned by November 5, 2012. Any product returned after November 5, 2012 will not be eligible for credit. For clinical or product support call 1-800-873-3636, option 6 or contact your local sales representative and reference Event 7283.
Quantity in Commerce 157,881 devices
Distribution Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of: ARGENTINA, AUSTRALIA, BAHRAIN, BELGIUM, BRAZIL, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, MALAYSIA, MEXICO, NEPAL, NICARAGUA, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, PUERTO RICO, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA, VIETNAM, and YEMEN. There was one Canadian consignee and 43 U.S. Government consignees.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GDW and Original Applicant = ETHICON ENDO-SURGERY, INC.
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