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Terminated

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.

FDA Recall Z-2097-2016 · Posted None

Recalling FirmCMP Industries, Llc
Recall StatusTerminated
Product CodeEBI
Date Initiated2016-04-28
Date Terminated2018-05-25
Product Quantity77 units Total

Reason for Recall

Possible presence of foreign material (rust).

Firm 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 [email protected].

Root Cause

Material/Component Contamination

Distribution Pattern

Domestic - MI, MN, NJ, NM, NY & PA; International - Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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