medical Class II Updated 2018-05-16

Straumann Manufacturing, Inc. recalls Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Arti

Recalled Product

Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099


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 LT830, Syringe Blister Lot LK692B, Exp 5/31/2018 Lot LZ706, Syringe Blister Lot LK692B, Exp 5/31/2018 Lot MG929, Syringe Blister Lot LK692B, Exp 5/31/2018 Lot MT037, Syringe Blister Lot MG253A, Exp 9/30/2018 Lot MZ441, Syringe Blister Lot MG253A, Exp 9/30/2018 Lot NJ289, Syringe Blister Lot MG253A, Exp 9/30/2018 Lot NJ579, Syringe Blister Lot NA438A, Exp 3/31/2019 Lot NP340, Syringe Blister Lot NA438A, Exp 3/31/2019
View official government recall

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