Device product
Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099
Z-1694-2018
Product summary
- Event
- Event 79738
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3046
- Official record key
device-enforcement:Z-1694-2018
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 LT830, Syringe Blister Lot LK692B, Exp 5/31/2018 Lot LZ706, Syringe Blister Lot LK692B, Exp 5/31/2018 Lot MG929, Syringe Blister Lot LK692B, Exp 5/31/2018 Lot MT037, Syringe Blister Lot MG253A, Exp 9/30/2018 Lot MZ441, Syringe Blister Lot MG253A, Exp 9/30/2018 Lot NJ289, Syringe Blister Lot MG253A, Exp 9/30/2018 Lot NJ579, Syringe Blister Lot NA438A, Exp 3/31/2019 Lot NP340, Syringe Blister Lot NA438A, 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.