Device product
IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards
Z-0292-2019
Product summary
- Event
- Event 81206
- Status
- Terminated
- Classification
- Class II
- Quantity
- 400 units
- Official record key
device-enforcement:Z-0292-2019
Official wording
Reason: Foreign material in product
Code information: Lot Number: 85623 , 85827
Distribution pattern: Worldwide distribution, US Nationwide in the states of CA, FL, IL, MI, NY, OK, OR, PA, TX, WA and countries of Canada and Spain.
Derived failure modes
-
Foreign material or chemical contamination
Foreign material