Device product
IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for relining a denture surface
Z-2098-2016
Product summary
- Event
- Event 74061
- Status
- Terminated
- Classification
- Class II
- Quantity
- 77 units Total
- Official record key
device-enforcement:Z-2098-2016
Official wording
Reason: Possible presence of foreign material (rust).
Code information: Lot Number: 79943 Expiration Date: March 2021
Distribution pattern: Domestic - MI, MN, NJ, NM, NY & PA; International - Canada
Derived failure modes
-
Foreign material or chemical contamination
foreign material