Device product
Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115
Z-1697-2018
Product summary
- Event
- Event 79738
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2356
- Official record key
device-enforcement:Z-1697-2018
Official wording
Reason: A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
Code information: Lot LZ713, Syringe Blaster Lot LP632B, Exp 6/30/2018 Lot MZ542, Syringe Blaster Lot LP632B, Exp 6/30/2018 Lot MG933, Syringe Blaster Lot LP632B, Exp 6/30/2018 Lot MZ543, Syringe Blaster Lot MG253C, Exp 9/30/2018 Lot NJ581, Syringe Blaster Lot MG253C, Exp 9/30/2018 Lot NJ582, Syringe Blaster Lot NA438B, Exp 3/31/2019 Lot NP345, Syringe Blaster Lot NE101B, Exp 3/31/2019
Distribution pattern: Distributed US Nationwide and Puerto Rico.
Derived failure modes
-
Unknown
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.