FDA recall Z-0293-2019

Product

Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1 REF: 3748GB. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards

Reason for recall

Foreign material in product

Distribution

Worldwide distribution, US Nationwide in the states of CA, FL, IL, MI, NY, OK, OR, PA, TX, WA and countries of Canada and Spain.

Key facts

Status

Terminated

Initiation date

2018-09-12

Report date

2018-11-07

Termination date

2020-05-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Albany, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0293-2019