FDA Medical Device Recalls (openFDA)
NDO Surgical, Inc.: Plicator EPS Plication System Catalog Number: 160-01128R
- Recall number
- Z-0685-2007
- Recalling firm
- NDO Surgical, Inc.
- Product
- Plicator EPS Plication System Catalog Number: 160-01128R
- Status
- Terminated
- Initiated
- 2007-01-26
- Posted
- 2007-03-31
- Terminated
- 2007-12-12
- 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.
- Lot, serial or model codes
- Serial Numbers: 43, 52, 54,59, 63, 65, 68, 72, 96,
- 510(k) numbers
- ["K032820"]
- PMA numbers
- not on file
- Product code
- KOG
- Firm FEI
- 3003309251
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28