BEUDAMED
    FDA Recall 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.

    Recall: Z-0057-2013 · Initiated August 3, 2012

    Recall

    Recall Number
    Z-0057-2013
    Event Number
    62879
    Firm
    Ethicon Endo-Surgery Inc
    FEI Number
    1527736
    Product Code
    GDW
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    August 3, 2012
    Posted
    October 13, 2012
    Terminated
    July 12, 2013
    Address
    4545 Creek Rd, Cincinnati, OH, 45242-2803

    Description

    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.

    Reason

    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.

    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.

    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.

    Quantity

    157,881 devices