Class 2 Device Recall Flexxus

• Date Initiated by Firm: March 14, 2007
• Date Posted: April 11, 2007
• Recall Status: Terminated on May 15, 2007
• Recall Number: Z-0729-2007
• Recall Event ID: 37628
• 510(K)Number: K031186
• Product Classification: Endoscopic Biliary Stent - Product Code FGE
• Product: Flexxus™ Endoscopic Biliary Stent, 7.5 Fr 10mm diameter x 40 mm length Item Number: LXB10040
• Code Information: Lot Numbers: ANQJO636, ANQJO637
• Recalling Firm/ Manufacturer: Conmed Endoscopic Technologies, Inc.; 129 Concord Rd Bldg 3; Billerica MA 01821-4600
• For Additional Information Contact: Beth Zis; 978-964-4251
• Manufacturer Reason for Recall: Blue safety clip incorrectly placed on the stent may prevent deployment
• FDA Determined Cause: Other
• Action: ConMed Endoscopic Technologies notified consignes by letter dated 3/14/07 requesting them to return recalled devices.
• Quantity in Commerce: 11 UNITS
• Distribution: Worldwide distribution, USA including states of DE, OH, MI, DC and countries of Belgium Japan.
• Total Product Life Cycle: TPLC Device Report

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 = FGE