Medical device recalls Moderate risk

Biom'up recalls RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.

Recall date
December 2, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1110-2017
FDA classification
Class II
Brand / firm
Biom'up
Sold / distributed
Distributed to a sole distributor in NC.

Why it was recalled

Lack of sterility assurance

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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