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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 Resinsee related information
Date Initiated by FirmMarch 02, 2016
Date PostedJune 29, 2016
Recall Status1 Terminated 3 on March 16, 2017
Recall NumberZ-2089-2016
Recall Event ID 73629
510(K)NumberK033020 
Product Classification Resin, denture, relining, repairing, rebasing - Product Code EBI
ProductIMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325cc), Part No. 3314 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325 cc), Part No. 3748 3) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, 1 Quart (946 cc), P/N 3306 4) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid PN 7450, 5) ThermoFlex ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS 1 Quart (946 cc) P/N 7465 Indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base
Code Information Lot Number 101113 
Recalling Firm/
Manufacturer		 CMP Industries, Llc
413 N Pearl St
Albany NY 12207-1311
For Additional Information ContactJohn Nicpon
518-434-3147
Manufacturer Reason
for Recall		Possible presence of foreign material (rust).
FDA Determined
Cause 2		Material/Component Contamination
ActionCMP Industries/Nobilium sent an Urgent IMPAK Recall letter dated March 2, 2016, to all affected customers via certified mail with return receipt in an attempt to verify if customers were in possession of the affected product. 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 posession subject to recall, please contact the firm by calling 518-434-3147, ext 144, Monday - Friday 8-4:30 pm, EST.
Quantity in Commerce236 pieces (25 pieces/11 oz, 211 pieces/1 Quart)
DistributionWorldwide Distribution - US including CA, MI, LA, OH, NY, IN, WA; Internationally: to CA
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = EBI
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