Straumann Manufacturing, Inc. recalls Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099
- Recall date
- March 23, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1694-2018
- FDA classification
- Class II
- Brand / firm
- Straumann Manufacturing, Inc.
- Sold / distributed
- Distributed US Nationwide and Puerto Rico.
Why it was recalled
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099
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