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Recall Observatory FDA recall evidence

Device product

Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W

Z-1698-2018

March 23, 2018

Class II

Product summary

Firm
Straumann Manufacturing, Inc.
Event
Event 79738
Status
Terminated
Classification
Class II
Quantity
1084
Official record key
device-enforcement:Z-1698-2018

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 NZ535, Syringe Blaster Lot LP632A, Exp 6/30/2018 Lot PG631, Syringe Blaster Lot MX842B, Exp 2/28/2019 Lot NP739, Syringe Blaster Lot NE101B, Exp 3/31/2019 Lot PY818, Syringe Blaster Lot PT888A, Exp 1/31/2020

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.