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.
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, 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.
- 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
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 →Related recalls
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Same hazard · efficacy uncertainty
See all →- ModerateStraumann Emdogain Recalled Due to Unverified Raw Material Shelf Life Changes
FDA (Devices) · 2018-05-16