IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for relining a denture surface
FDA Recall Z-2098-2016 · Posted None
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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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