Device product
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.
Z-1089-2016
Product summary
- Event
- Event 71148
- Status
- Terminated
- Classification
- Class II
- Quantity
- 246 units
- Official record key
device-enforcement:Z-1089-2016
Official wording
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.
Code information: Lot Number 103113
Distribution pattern: Worldwide Distribution -- USA, to the states of MI, NJ, PA, and TX; and, the country of Canada.
Derived failure modes
-
Unknown
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.