Home / Recalls / Medical Devices
Straumann Manufacturing, Inc. recalls Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W
Recalled May 16, 2018 · FDA recall Z-1698-2018 · 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
1084
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 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W
Manufacturer(s)
Straumann Manufacturing, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →