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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:142341

Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE¿ III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.

Official recall number

Z-0602-2016

Evidence summary

Product code
PFJ
Recall status
Terminated
Event initiated
December 03, 2015
Root cause
Device Design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0602-2016