Recall Z-1237-2018 ยท GDW Staple, Implantable
Covidien LLC
Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.
| Date | Dec 13, 2017 |
| Status | Terminated |
| Reason | Product reportedly shutting down during use. |
| Root cause | Component design/selection |
| Action | The firm, Medtronic, sent a "Field Corrective Action Notice" dated 12/13/2017 to all consignees via Federal Express or certified mail on 12/13/17. The notice described the product, problem and actions to be taken. Customers were instructed to: immediately notify all users of Signia power handles of this important notification; follow the User manual and Instructions for Use; If your facility has distributed Signia" power handles to other persons or facilities, please promptly forward a copy of this letter to those recipients, and complete and return the Field Corrective Action Acknowledgement |
| Quantity | 2121 |
| Distribution | Worldwide Distribution: US (Nationwide). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160176 | Signia Stapler Covidien, Apr 26, 2016 |