Class 2 Device Recall IMPAK ELASTIC ACRYLIC RESIN LIQUID

• Date Initiated by Firm: September 12, 2018
• Create Date: October 30, 2018
• Recall Status: Terminated on May 19, 2020
• Recall Number: Z-0293-2019
• Recall Event ID: 81206
• Product Classification: Resin, denture, relining, repairing, rebasing - Product Code EBI
• 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
• Code Information: Lot Number: 85827
• FEI Number: 1315551
• Recalling Firm/ Manufacturer: CMP Industries, Llc; 413 N Pearl St; Albany NY 12207-1311
• For Additional Information Contact: SAME; 518-434-3147
• Manufacturer Reason for Recall: Foreign material in product
• FDA Determined Cause: Material/Component Contamination
• 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).
• Quantity in Commerce: 40 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.