Recall Z-2097-2016 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
CMP Industries, Llc
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 Liqu
| 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 |