Recall Z-0203-2020 ยท GDW Staple, Implantable
Ethicon Endo-Surgery Inc
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A
| Date | Oct 29, 2019 (initiated Oct 3, 2019) |
| Status | Terminated |
| Reason | The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death. |
| Root cause | Nonconforming Material/Component |
| Action | Urgent Medical Device Recall (Removal) letters were sent to customers beginning 10/3/19. The letters instruct customers to do the following: ACTION REQUIRED: 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 voluntary recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this recall has been forwarded to another facility, contact that facility to |
| Quantity | 2112 units |
| Distribution | Worldwide distribution. US Nationwide. Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140560 | ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING Ethicon Endo-Surgery, LLC, Apr 22, 2014 |