Recall Z-2089-2016 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
CMP Industries, Llc
IMPAK 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 A
| Date | Jun 29, 2016 (initiated Mar 2, 2016) |
| Status | Terminated |
| Reason | Possible presence of foreign material (rust). |
| Root cause | Material/Component Contamination |
| Action | CMP 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 |
| Quantity | 236 pieces (25 pieces/11 oz, 211 pieces/1 Quart) |
| Distribution | Worldwide Distribution - US including CA, MI, LA, OH, NY, IN, WA; Internationally: to CA |
| 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 |