Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0729-2007

Flexxus™ Endoscopic Biliary Stent, 7.5 Fr 10mm diameter x 40 mm length Item Number: LXB10040

Conmed Endoscopic Technologies, Inc. / initiated 2007-03-14 / Terminated

Conmed Endoscopic Technologies, Inc. began a recall of Flexxus™ Endoscopic Biliary Stent, 7.5 Fr 10mm diameter x 40 mm length Item Number: LXB10040 on . The reason FDA records is "Blue safety clip incorrectly placed on the stent may prevent deployment". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0729-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Conmed Endoscopic Technologies, Inc.
Product
Flexxus™ Endoscopic Biliary Stent, 7.5 Fr 10mm diameter x 40 mm length Item Number: LXB10040
Product code
FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall
Blue safety clip incorrectly placed on the stent may prevent deployment
FDA root 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.
Product codes and lots
Lot Numbers: ANQJO636, ANQJO637