Recall Z-2326-2021 ยท GDW Staple, Implantable
Ethicon Endo-Surgery Inc
ECHELON FLEX Powered Plus Stapler-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. Product Code: PSEE60A
| Date | Jun 3, 2021 |
| Status | Terminated |
| Reason | Mislabeled: Labeled on the package as 60mm contains 45mm devices |
| Root cause | Packaging change control |
| Action | Ethicon notified US consignees by Urgent Medical Device removal letter on 6/3/21 via Fed-Ex second day. Ethicon Johnson & Johnson Affiliates in impacted countries will notify their customers and health authorities per their local regulations and procedures. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2. Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyon |
| Quantity | 763 eaches |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of MD, WA and the countries of Belgium, China, Denmark, Estonia, France, Germany, Italy, Japan, Korea, Latvia, Lithuania, Netherlands, Poland, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202665 | Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endos Ethicon Endo-Surgery, LLC, Oct 15, 2020 |