Straumann Emdogain 015 Recall: Shelf Life Change Risk

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Recalling firmStraumann Manufacturing, Inc.60 Minuteman Rd, N/A · Andover, MA 01810-1008

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Straumann is recalling Emdogain 015 (Article 075.099) because a raw material's shelf life was changed without proper testing to ensure the product still works. This could mean the product might not be effective when used.

Why it’s dangerous

The recall is due to a change in the shelf life of a raw material that wasn't properly tested to confirm the product remains effective. This could lead to reduced effectiveness of the product in dental treatments.

Who’s affected

Patients using Emdogain 015 for dental procedures may be affected. Those with specific lot numbers listed are most at risk.

How to tell if you have this one

Check for the product name 'Emdogain 015', Article Number 075.099, and specific lot numbers listed in the recall notice (e.g., LT830, LK692B, etc.).

Brand
Straumann
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the product name, Article Number, and lot numbers listed in the recall notice to confirm if your item is affected.

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Questions people ask

Is there a remedy for this recall?

The official recall notice does not provide any remedy steps.

Which lots are affected?

Affected lots include LT830, LK692B, LZ706, MG929, MT037, MZ441, NJ289, NJ579, NP340, and others with specific expiration dates.

Why was this product recalled?

Straumann implemented a change to the shelf life of a raw material without submitting data to prove the product still works effectively.

Take action

Contact Straumann

We’ve drafted a message you can send Straumann to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1694-2018 — Straumann Straumann

Hello,

I own a Straumann that is covered by recall Z-1694-2018 from Straumann.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1694-2018 (March 23, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1694-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Straumann Manufacturing, Inc. recalls Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099

Lower-risk recall