Class 2 Device Recall NDO Surgical Plicator EPS

• Date Initiated by Firm: January 26, 2007
• Date Posted: March 31, 2007
• Recall Status: Terminated on December 12, 2007
• Recall Number: Z-0685-2007
• Recall Event ID: 37247
• 510(K)Number: K032820
• Product Classification: Endoscope - Product Code KOG
• Product: Plicator EPS Plication System Catalog Number: 160-01128R
• Code Information: Serial Numbers: 43, 52, 54,59, 63, 65, 68, 72, 96,
• FEI Number: 3003309251
• Recalling Firm/ Manufacturer: NDO Surgical, Inc.; 125 High St Ste 7; Mansfield MA 02048-2165
• For Additional Information Contact: Jennifer Almy; 508-337-8881 Ext. 122
• Manufacturer Reason for Recall: Device arm may fail to open after being deployed and require surgical intervention to remove
• FDA Determined 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.

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• 510(K) Database: 510(K)s with Product Code = KOG