medical Class II Updated 2018-05-16

Straumann Manufacturing, Inc. recalls Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative

Recalled Product

Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot NP737, Syringe Blister Lot NA438A, Exp 3/31/2019; Lot PG628, Syringe Blister Lot NF819A, Exp 3/31/2019; Lot PY816, Syringe Blister Lot PT888C, Exp 1/31/2020; Lot NY939, Syringe Blister Lot, NA438A, Exp 3/31/2019
View official government recall

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