Device product
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
Z-2089-2016
Product summary
- Event
- Event 73629
- Status
- Terminated
- Classification
- Class II
- Quantity
- 236 pieces (25 pieces/11 oz, 211 pieces/1 Quart)
- Official record key
device-enforcement:Z-2089-2016
Official wording
Reason: Possible presence of foreign material (rust).
Code information: Lot Number 101113
Distribution pattern: Worldwide Distribution - US including CA, MI, LA, OH, NY, IN, WA; Internationally: to CA
Derived failure modes
-
Foreign material or chemical contamination
foreign material