FDA Enforcement
Class II
Terminated
IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 1 Quart (946 ML), REF 3306, Rx ONLY; 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 11 oz (325 ML), REF 3748, Rx ONLY, 3) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid, PN 7450; Indicated for relining a denture surface.
Recall: Z-2097-2016
·
Reported July 6, 2016
Enforcement
- Recall Number
- Z-2097-2016
- Event ID
- 74061
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- CMP Industries, Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 6, 2016
- Initiation Date
- April 28, 2016
- Classification Date
- June 29, 2016
- Termination Date
- May 25, 2018
- Address
- 413 N Pearl St, Albany, NY, 12207-1311, United States
Description
IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 1 Quart (946 ML), REF 3306, Rx ONLY; 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 11 oz (325 ML), REF 3748, Rx ONLY, 3) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid, PN 7450; Indicated for relining a denture surface.
Reason
Possible presence of foreign material (rust).
Code Info
Lot Number: 79943 Expiration Date: March 2021
Distribution
Domestic - MI, MN, NJ, NM, NY & PA; International - Canada
Quantity
77 units Total