Recall Z-1089-2016— CMP Industries, Llc

Name: FDA recall Z-1089-2016
Creator: U.S. Food and Drug Administration
Published: 2013-11-18

Class II · Terminated

Class II FDA medical device recall by CMP Industries, Llc, initiated 2013-11-18, terminated 2018-05-23. It names one FDA 510(k) clearance: K033020. 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.. 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..

Recalling firm: CMP Industries, Llc
Classification: Class II
Status: Terminated
Initiated: 2013-11-18
Terminated: 2018-05-23
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 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.

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