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Straumann Manufacturing, Inc. recalls Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W
Recalled May 16, 2018 · FDA recall Z-1693-2018 · Straumann Manufacturing
Hazard
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. · FDA Class II
Units
2381
Sold at
Distributed US Nationwide and Puerto Rico.
Description
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.
Product
Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W
Manufacturer(s)
Straumann Manufacturing, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →