Z-2089-2016 Class II Terminated
FDA device recall Z-2089-2016 was initiated by CMP Industries, Llc on March 2, 2016 and is designated Class II. Reason for recall: Possible presence of foreign material (rust). The recall status is terminated (terminated March 16, 2017). Affected quantity: 236 pieces (25 pieces/11 oz, 211 pieces/1 Quart).
Recall Details
- Product Type
- Devices
- Report Date
- July 6, 2016
- Initiation Date
- March 2, 2016
- Termination Date
- March 16, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 236 pieces (25 pieces/11 oz, 211 pieces/1 Quart)
Product Description
IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325cc), Part No. 3314 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325 cc), Part No. 3748 3) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, 1 Quart (946 cc), P/N 3306 4) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid PN 7450, 5) ThermoFlex ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS 1 Quart (946 cc) P/N 7465 Indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base
Reason for Recall
Possible presence of foreign material (rust).
Distribution Pattern
Worldwide Distribution - US including CA, MI, LA, OH, NY, IN, WA; Internationally: to CA
Code Information
Lot Number 101113