Ethicon Endo-Surgery Inc: Medical Device Recall in 2012 - (Recall #: Z-0057-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product 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.

Product Classification:

Class I

Date Initiated: August 3, 2012

Date Posted: October 24, 2012

Recall Number: Z-0057-2013

Event ID: 62879

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.

Status: Terminated

Product Quantity: 157,881 devices

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated