Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-0057-2013 · Posted 2012-10-13

Recalling FirmEthicon Endo-Surgery Inc
Recall StatusTerminated
Product CodeGDW
Date Initiated2012-08-03
Date Terminated2013-07-12
Product Quantity157,881 devices

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.

Firm 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.

Root Cause

Process change control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051301PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIESEthicon Endo-Surgery, Inc. · 2005-08-30K030925PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01Ethicon Endo-Surgery, Inc. · 2003-05-15K030411PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03Ethicon Endo-Surgery, Inc. · 2003-03-20K991030PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIESEthicon Endo-Surgery, Inc. · 1999-05-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑