The Recall Desk
ModerateFDA (Devices)·Z-1693-2018·Announced 2018-05-16

Straumann Emdogain Recalled Due to Unverified Raw Material Shelf Life Changes

Straumann Manufacturing is recalling Emdogain Enamel Matrix Derivative because a raw material shelf life change was implemented without submitting data to demonstrate continued product efficacy.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a lack of data demonstrating continued efficacy due to a raw material change, which is a quality control issue rather than a direct physical hazard like infection or injury. No illnesses or injuries are reported.

Plain-English summary

Straumann Manufacturing, Inc. is recalling Straumann Emdogain 0.15 ml 5-Pack, an Enamel Matrix Derivative (Article Number 075.098W). The recall involves 2,381 units distributed nationwide in the United States and Puerto Rico.

The recall was initiated because 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. The affected lots include NP737, PG628, PY816, and NY939, with expiration dates ranging from January 31, 2020, to March 31, 2019.

Consumers and healthcare providers should stop using the affected product and contact Straumann Manufacturing, Inc. for further instructions or a refund.

The recalled product

Product
Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W
Manufacturer
Straumann Manufacturing, Inc.
Category
Medical Device — Dental / Regenerative
Hazard
Affected units
2,381

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 6 recalled by Straumann Manufacturing, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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