Recall Z-0685-2007 ยท KOG
NDO Surgical, Inc.
Plicator EPS Plication System Catalog Number: 160-01128R
| Date | Mar 31, 2007 (initiated Jan 26, 2007) |
| Status | Terminated |
| Reason | Device arm may fail to open after being deployed and require surgical intervention to remove |
| Root cause | Process design |
| Action | NDO Surgical notified accounts by letter on 1/26/07 advising to quarantine units. Replacement units are being sent and recalled devices are requested to be returned. |
| Quantity | 9 units |
| Distribution | Worldwide distribution, USA including states of AZ, GA, NH, NY, TN and country of Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032820 | MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM Ndo Surgical, Inc., Oct 23, 2003 |