FDA-Device2017-02-08Class II

RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.

Biom'up
Hazard

Lack of sterility assurance

Sold states
Distributed to a sole distributor in NC.
Affected count
1,682 units
Manufactured in
Batiment 7, 8 allee Irene Joliot Curie, St Priest, N/A, France
Products
RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1110-2017

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief