Recall Z-2098-2016 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
CMP Industries, Llc
IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for relining a denture surface
| Date | Apr 28, 2016 |
| Status | Terminated |
| Reason | Possible presence of foreign material (rust). |
| Root cause | 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 |
| Quantity | 77 units Total |
| Distribution | Domestic - MI, MN, NJ, NM, NY & PA; International - Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033020 | IMPAK ACRYLIC REPAIR RESIN LIQUID Cmp Industries, LLC, Dec 19, 2003 |