medical Class II Updated 2018-05-16

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

Recalled Product

Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114W


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 NY938, Syringe Blister Lot MN843, Exp 11/30/2018 Lot NP738, Syringe Blister Lot NE101A, Exp 3/31/2019 Lot PG629, Syringe Blister Lot NK216, Exp 5/31/2019 Lot PY817, Syringe Blister Lot PT888C, Exp 1/31/2020
View official government recall

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