Z-0685-2007

Plicator EPS Plication System Catalog Number: 160-01128R

Name: Z-0685-2007 Plicator EPS Plication System Catalog Number: 160-01128R
Creator: NDO Surgical, Inc.
Published: 2007-01-26
License: https://open.fda.gov/license/

Ndo Surgical, Inc. / initiated 2007-01-26 / Terminated / root cause: manufacturing process

FDA source

NDO Surgical, Inc. began a recall of Plicator EPS Plication System Catalog Number: 160-01128R on 2007-01-26. The reason FDA records is "Device arm may fail to open after being deployed and require surgical intervention to remove". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0685-2007
Status: Terminated
Initiated: 2007-01-26
Posted: 2007-03-31
Terminated: 2007-12-12
Recalling firm: Ndo Surgical, Inc.
Product: Plicator EPS Plication System Catalog Number: 160-01128R
Product code: KOG
Reason for recall: Device arm may fail to open after being deployed and require surgical intervention to remove
Root cause tag: manufacturing process
FDA 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 in commerce: 9 units
Distribution: Worldwide distribution, USA including states of AZ, GA, NH, NY, TN and country of Germany.
Product codes and lots: Serial Numbers: 43, 52, 54,59, 63, 65, 68, 72, 96,

Product code KOG

K032820Class IIModification to Endoscopic Plication SystemNdo Surgical, Inc. / cleared 2003-10-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)