Plicator EPS Plication System Catalog Number: 160-01128R
FDA Recall Z-0685-2007 · Posted 2007-03-31
Recalling FirmNDO Surgical, Inc.
Recall StatusTerminated
Product CodeKOG
Date Initiated2007-01-26
Date Terminated2007-12-12
Product Quantity9 units
Reason for Recall
Device arm may fail to open after being deployed and require surgical intervention to remove
Firm 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.
Root Cause
Process design
Distribution Pattern
Worldwide distribution, USA including states of AZ, GA, NH, NY, TN and country of Germany.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.