Recall Z-3187-2011 ยท GDW Staple, Implantable
Ethicon Endo-Surgery Inc
ENDOPATH ETS Compact Flex (240 mm shaft length) Linear Cutters, Model Number(s): SCW45; CTS45; SCB45; CTS45NK; 6CB45 and SCG45. Mfr. By: Ethicon Endo-Surgery, LLC, Guaynabo, PR 00969 The ETS Compact-Flex45 Articulating Linear Cutter is intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic,
| Date | Sep 12, 2011 (initiated Jul 29, 2011) |
| Status | Terminated |
| Reason | Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENDOPATH ETS Compact Flex 45mm articulating linear cutters because the possibility exists that damage to the blister pack may have compromised the sterility of the device. |
| Root cause | Packaging |
| Action | Ethicon Endo-Surgery Inc sent an URGENT DEVICE RECALL letter dated August 11, 2011 to all affected customers. The letter identified the product, the problem, the action to be taken by the customer. Customers were instructed to examine their inventory immediately to determine if they have any of the affected product. Fill out the Business Reply Form and fax it to 1-866-853-2802 if they have any of the affected product. To ensure adequate identification of the return product at their facility customers should complete the Customer Purchase Order Field on the Business Reply Form. For any q |
| Quantity | 27,582 instruments |
| Distribution | Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI and WV and the countries of ARGENTINA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, CZECH REPUBLIC, GREE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020779 | PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS Ethicon Endo-Surgery, Inc., Jun 5, 2002 |
| K061156 | ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS Ethicon Endo-Surgery, Inc., Jul 3, 2006 |
| K070887 | ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS) Ethicon Endo-Surgery, LLC, May 25, 2007 |