Recall Z-0636-2018 ยท GDW Staple, Implantable
Covidien LLC
Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
| Date | Feb 16, 2018 (initiated Sep 13, 2017) |
| Status | Terminated |
| Reason | Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time. |
| Root cause | Under Investigation by firm |
| Action | All consignees were notified via Federal Express or certified mail on September 13, 2017, and the letter informs customers of the potential for failure of the device safety interlock and the actions they should take. Customers are requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice. All in control inventory and product returned from customers will be scrapped. |
| Quantity | 3,816 |
| Distribution | Nationally |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111825 | ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS Covidien, Formerly US Surgical A Divison of Tyco H, Oct 25, 2011 |