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U.S. Department of Health and Human Services

Class 2 Device Recall IMPAK Liquid Acrylic Resin

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  Class 2 Device Recall IMPAK Liquid Acrylic Resin see related information
Date Initiated by Firm April 28, 2016
Create Date June 29, 2016
Recall Status1 Terminated 3 on May 25, 2018
Recall Number Z-2097-2016
Recall Event ID 74061
510(K)Number K033020  
Product Classification Resin, denture, relining, repairing, rebasing - Product Code EBI
Product IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 1 Quart (946 ML), REF 3306, Rx ONLY; 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 11 oz (325 ML), REF 3748, Rx ONLY, 3) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid, PN 7450; Indicated for relining a denture surface.
Code Information Lot Number: 79943 Expiration Date: March 2021
Recalling Firm/
Manufacturer		 CMP Industries, Llc
413 N Pearl St
Albany NY 12207-1311
For Additional Information Contact John Nicpon
518-434-3147
Manufacturer Reason
for Recall		 Possible presence of foreign material (rust).
FDA Determined
Cause 2		 Material/Component Contamination
Action On April 28, 2016, Nobilium, Division of CMP Industries LLC distributed Urgent Recall notices and Response Forms to their customers via courier service. Customers were advised to immediately examine inventory and to quarantine product subject to the recall. In addition, if customers further distributed the product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of the notice. If customers have any of the product in their possession subject to recall, please contact the firm by calling John Nicpon at 518-434-3147, ext. 144. Hours of operation are Monday - Friday 8-4:30 pm, EST. Return completed recall response forms to nicpon@nobilium.com.
Quantity in Commerce 77 units Total
Distribution Domestic - MI, MN, NJ, NM, NY & PA; International - Canada
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.
510(K) Database 510(K)s with Product Code = EBI and Original Applicant = CMP INDUSTRIES LLC.
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