Osteogenics Biomedical, Inc. recalls Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable) for use as…
- Recall date
- September 7, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0113-2017
- FDA classification
- Class II
- Brand / firm
- Osteogenics Biomedical, Inc.
- Sold / distributed
- Worldwide Distribution - US Distribution and to the countries of : Colombia, Venezuela/Ecuador, Japan, India, Canada, and UK.
Why it was recalled
The device has the potential to be packaged in the wrong product box.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal bone defects.
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