medical Class II Updated 2018-05-16

Straumann Manufacturing, Inc. recalls Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivati

Recalled Product

Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W


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 NZ535, Syringe Blaster Lot LP632A, Exp 6/30/2018 Lot PG631, Syringe Blaster Lot MX842B, Exp 2/28/2019 Lot NP739, Syringe Blaster Lot NE101B, Exp 3/31/2019 Lot PY818, Syringe Blaster Lot PT888A, Exp 1/31/2020
View official government recall

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