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, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials.

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.

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 questions regarding this recall call 1-866-708-2330 and reference Event 2471. For clinical or product support call 1-800-USE-ENDO, option 6, or contact your local sales representative.