Recall Z-1089-2016 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
CMP Industries, Llc
IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748. Indicated for relining a denture surface for repairing a fractured denture, or forming a new denture base.
| Date | Mar 9, 2016 (initiated Nov 18, 2013) |
| Status | Terminated |
| Reason | During the current inspection of CMP Industries, the FDA Investigator discovered that the firm had conducted a recall of Impak Acrylic Liquid Batch 103113 in 2013 due to potential rust without notifying the district. |
| Root cause | Nonconforming Material/Component |
| Action | On November 18, 2013, CMP Customer Service contacted customers by telephone requesting return of the affected product and customers were issued a UPS Call Tag. CMP issued a letter to non-responding customers dated December 9, 2013, requesting return of the product because of the possibility of foreign particles. The letter states, the firm found that one of their processes could deliver a material that would pass their QC tests, but may introduce foreign material into the liquid. A customer service representative will be in contact with customers to arrange the return of the product. |
| Quantity | 246 units |
| Distribution | Worldwide Distribution -- USA, to the states of MI, NJ, PA, and TX; and, the country of 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 |