Z-1089-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 16, 2016
- Initiation Date
- November 18, 2013
- Termination Date
- May 23, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 246 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution -- USA, to the states of MI, NJ, PA, and TX; and, the country of Canada.
Code Information
Lot Number 103113