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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