Recall Z-2174-2017 ยท GDW Staple, Implantable
Ethicon Endo-Surgery Inc
Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
| Date | Mar 31, 2017 |
| Status | Terminated |
| Reason | There is a risk that the pinion gear in the device could fail under extreme use cases. |
| Root cause | Process control |
| Action | Consignees were sent notification letters and were asked to complete the Business Reply Form (BRF). |
| Quantity | 792 units |
| Distribution | Worldwide distribution. The previously recalled products were distributed to the following countries: China, Japan, Singapore, and South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111111 | ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO Ethicon Endo-Surgery, LLC, Jun 8, 2011 |