Recall Z-2098-2016— CMP Industries, Llc

Name: FDA recall Z-2098-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-28

Class II · Terminated

Class II FDA medical device recall by CMP Industries, Llc, initiated 2016-04-28, terminated 2018-05-25. It names one FDA 510(k) clearance: K033020. Product: IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for relining a denture surface. Reason: Possible presence of foreign material (rust)..

Recalling firm: CMP Industries, Llc
Classification: Class II
Status: Terminated
Initiated: 2016-04-28
Terminated: 2018-05-25
Firm location: Albany, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K033020 — IMPAK ACRYLIC REPAIR RESIN LIQUIDCmp Industries, LLC·cleared 2003-12-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Possible presence of foreign material (rust).

Data sourced from openFDA. This site is unofficial and independent of the FDA.