Plicator EPS Plication System Catalog Number: 160-01128R
FDA device recall Z-0685-2007 · posted 2007-03-31 · Terminated
Recall details
- Recalling firm
- NDO Surgical, Inc.
- Reason for recall
- Device arm may fail to open after being deployed and require surgical intervention to remove
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- KOG
- Quantity affected
- 9 units
- Distribution
- Worldwide distribution, USA including states of AZ, GA, NH, NY, TN and country of Germany.
- Date initiated
- 2007-01-26
- Date posted
- 2007-03-31
- Date terminated
- 2007-12-12
- Location
- Mansfield, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM (K032820) | Ndo Surgical, Inc. | 2003-10-23 |