The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1696-2018·Announced 2018-05-16

Straumann Emdogain Recalled Due to Unverified Raw Material Shelf Life Changes

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

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a procedural failure regarding efficacy verification rather than a direct physical danger like contamination or structural failure, fitting the 'Moderate' criteria for low-risk or precautionary issues.

Plain-English summary

Straumann Manufacturing, Inc. is recalling 2,915 units of Straumann Emdogain 0.3 ml Multipack (Article Number 075.114W). The product is an Enamel Matrix Derivative used in medical procedures. The affected units were distributed nationwide in the United States and in 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. This procedural gap means the manufacturer has not provided the necessary evidence to confirm that the product remains effective under the new conditions.

The recall covers specific lots with the following expiration dates: Lot NY938 (Exp 11/30/2018), Lot NP738 (Exp 3/31/2019), Lot PG629 (Exp 5/31/2019), and Lot PY817 (Exp 1/31/2020). Healthcare providers and patients who have used or possess these specific lots should contact Straumann Manufacturing for further instructions on how to handle the product.

The recalled product

Product
Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114W
Manufacturer
Straumann Manufacturing, Inc.
Category
Medical Device — Dental / Regenerative Medicine
Hazard
Affected units
2,915

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 (9)

  • Lot NY938
  • Syringe Blister Lot MN843
  • Exp 11/30/2018 Lot NP738
  • Syringe Blister Lot NE101A
  • Exp 3/31/2019 Lot PG629
  • Syringe Blister Lot NK216
  • Exp 5/31/2019 Lot PY817
  • Syringe Blister Lot PT888C
  • Exp 1/31/2020

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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