medical Class II Updated 2018-05-16

Straumann Manufacturing, Inc. recalls Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Deri

Recalled Product

Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.113


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 MZ538, Syringe Blister Lot MG253B, Exp 9/4/2018 Lot NJ580, Syringe Blister Lot MG253B, Exp 9/30/2018 Lot NK215, Syringe Blister Lot NE101A, Exp 3/31/2019 Lot NP343, Syringe Blister Lot NE101A, Exp 3/31/2019
View official government recall

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