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Recall Observatory FDA recall evidence

Device product

Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W

Z-1693-2018

March 23, 2018

Class II

Product summary

Firm
Straumann Manufacturing, Inc.
Event
Event 79738
Status
Terminated
Classification
Class II
Quantity
2381
Official record key
device-enforcement:Z-1693-2018

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 NP737, Syringe Blister Lot NA438A, Exp 3/31/2019; Lot PG628, Syringe Blister Lot NF819A, Exp 3/31/2019; Lot PY816, Syringe Blister Lot PT888C, Exp 1/31/2020; Lot NY939, 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.