FDA recall Z-1694-2018

Product

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

Reason for recall

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.

Distribution

Distributed US Nationwide and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2018-03-23

Report date

2018-05-16

Termination date

2019-05-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1694-2018