Device product
Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1 REF: 3748GB. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards
Z-0293-2019
Product summary
- Event
- Event 81206
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 units
- Official record key
device-enforcement:Z-0293-2019
Official wording
Reason: Foreign material in product
Code information: Lot Number: 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