Medical device recalls Moderate risk

IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID recalled over foreign material

Recall date
April 28, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
CMP Industries, Llc recalls IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ON…
Recall number
Z-2098-2016
FDA classification
Class II
Brand / firm
CMP Industries, Llc
Sold / distributed
Domestic - MI, MN, NJ, NM, NY & PA; International - Canada

Why it was recalled

Possible presence of foreign material (rust).

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 ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for relining a denture surface

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