FDA Enforcement
Class II
Terminated
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.
Recall: Z-1089-2016
·
Reported March 16, 2016
Enforcement
- Recall Number
- Z-1089-2016
- Event ID
- 71148
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- CMP Industries, Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 16, 2016
- Initiation Date
- November 18, 2013
- Classification Date
- March 9, 2016
- Termination Date
- May 23, 2018
- Address
- 413 N Pearl St, N/A, Albany, NY, 12207-1311, United States
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
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.
Code Info
Lot Number 103113
Distribution
Worldwide Distribution -- USA, to the states of MI, NJ, PA, and TX; and, the country of Canada.
Quantity
246 units