Device evidence

device-recall:cfres:189632

SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

Official recall number

Z-0216-2022

Evidence summary

Product code: FGE
Recall status: Open, Classified
Event initiated: October 01, 2021
Root cause: Process control
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0216-2022