Agency classClass IIOur severity:Moderate FDA (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.

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. 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: efficacy-uncertainty
quality-control
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 →

Same manufacturer · Straumann Manufacturing, Inc.

See all →

Moderate
Straumann Recalls Neodent GM Mini Conical Abutments Due to Label Mismatch
FDA (Devices) · 2018-11-21
High
Straumann Emdogain Recalled for Unverified Raw Material Shelf Life Change
FDA (Devices) · 2018-05-16
High
Straumann Emdogain Recalled Due to Unverified Raw Material Shelf Life Change
FDA (Devices) · 2018-05-16
High
Straumann Emdogain Recall Due to Shelf Life Data Issue
FDA (Devices) · 2018-05-16
Moderate
Straumann Emdogain Recalled Due to Unverified Raw Material Shelf Life Changes
FDA (Devices) · 2018-05-16

Same hazard · efficacy uncertainty