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U.S. Department of Health and Human Services

Enforcement Report - Week of October 24, 2012

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Event Detail

Event ID 62879
Product Type Devices
Status Ongoing
Recalling Firm Ethicon Endo-Surgery Inc
City Cincinnati
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-03
Initial Firm Notification of
Consignee or Public
Letter
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 musculomucosal 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. 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 Class I 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. 157,881 devices Z-0057-2013
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