Recall Z-0057-2013 ยท GDW Staple, Implantable
Ethicon Endo-Surgery Inc
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 gene
| Date | Oct 13, 2012 (initiated Aug 3, 2012) |
| Status | Terminated |
| 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. |
| Root cause | 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 fo |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030411 | PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03 Ethicon Endo-Surgery, Inc., Mar 20, 2003 |
| K030925 | PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01 Ethicon Endo-Surgery, Inc., May 15, 2003 |
| K051301 | PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES Ethicon Endo-Surgery, Inc., Aug 30, 2005 |
| K991030 | PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES Ethicon Endo-Surgery, Inc., May 17, 1999 |