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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:141612

Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.

Official recall number

Z-0366-2016

Evidence summary

Product code
LMH
Recall status
Terminated
Event initiated
October 26, 2015
Root cause
Other
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0366-2016

Field note

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