Z-2097-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 6, 2016
- Initiation Date
- April 28, 2016
- Termination Date
- May 25, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 77 units Total
Product 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 for Recall
Possible presence of foreign material (rust).
Distribution Pattern
Domestic - MI, MN, NJ, NM, NY & PA; International - Canada
Code Information
Lot Number: 79943 Expiration Date: March 2021