Skip to content
Recall Observatory FDA recall evidence

Device product

Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115

Z-1697-2018

March 23, 2018

Class II

Product summary

Firm
Straumann Manufacturing, Inc.
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

    reason.no_named_rule · v1.0.0

    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.