Straumann recalls Emdogain 0.3ml Multipacks with specific lot numbers due to unverified shelf life changes in raw materials. Affected products may not be effective after expiration.
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.
Straumann is recalling Emdogain 0.3ml Multipacks with certain lot numbers because a raw material's shelf life was changed without proper testing. This could mean the product isn't effective after its expiration date.
The recall is due to a change in the raw material's shelf life that wasn't properly tested. This could mean the product loses effectiveness after its expiration date, but it doesn't cause immediate harm.
People who own or use Emdogain 0.3ml Multipacks with the listed lot numbers. Those using the product for medical purposes are most at risk if the product becomes ineffective.
Check the lot numbers on the packaging: MZ538, MG253B, NJ580, NP343, or NE101A with specific expiration dates listed.
Look for lot numbers MZ538, MG253B, NJ580, NP343, or NE101A on the packaging.
The recall is because a change in the raw material's shelf life was made without proper testing to ensure the product remains effective.
Check the lot numbers on the packaging to see if it's affected. If it is, you may need to contact Straumann for guidance.
No immediate injury risk, but the product may not be effective after its expiration date.
We’ve drafted a message you can send Straumann to request your refund or repair — edit it as you like.
Subject: Recall Z-1695-2018 — Straumann Straumann Hello, I own a Straumann that is covered by recall Z-1695-2018 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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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.
