CMP Industries, Llc recalls IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (32…

Recall date

November 18, 2013

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1089-2016

FDA classification

Class II

Brand / firm

CMP Industries, Llc

Sold / distributed

Worldwide Distribution -- USA, to the states of MI, NJ, PA, and TX; and, the country of Canada.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.