Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0293-2019 · Posted None

Recalling FirmCMP Industries, Llc
Recall StatusTerminated
Product CodeEBI
Date Initiated2018-09-12
Date Terminated2020-05-19
Product Quantity40 units

Reason for Recall

Foreign material in product

Firm Action

Nobilium, A Division of CMP Industries LLC notified customer by phone and certified mail on 9/12/18 advising users of the problem and to return product.. Distributors requested to notify the user level (dental laboratory who processed this material. Questions, call 518-434-3147, extension 144, M-F 8-4:30pm (Eastern).

Root Cause

Material/Component Contamination

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑