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Recall Observatory FDA recall evidence

Device product

Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099

Z-1694-2018

March 23, 2018

Class II

Product summary

Firm
Straumann Manufacturing, Inc.
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

    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.