Straumann recalls Emdogain 0.15 ml 5-Pack due to unapproved shelf life change in raw materials. Affected items have specific lot numbers and expiration dates. Consumers should contact Straumann for details.
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 0.15 ml 5-Pack products because a raw material's shelf life was changed without proper testing. This could affect product effectiveness and safety, though the recall doesn't specify immediate harm.
The recall states that a raw material's shelf life was changed without proper data showing the product remains effective. This could mean the product might not work as intended, but it does not indicate immediate safety risks.
People who own or use Emdogain 0.15 ml 5-Pack products with specific lot numbers and expiration dates. Those most at risk are users who rely on the product for medical purposes.
Check for lot numbers: NP737, PG628, PY816, or NY939 with syringe blister lots NA438A, NF819A, or PT888C. Products expire by March 31, 2019, or January 31, 2020.
Look for lot numbers NP737, PG628, PY816, or NY939 on the product packaging.
The recall is due to a change in the raw material's shelf life that wasn't properly tested for product effectiveness.
No, the recall does not require stopping use; it only affects product effectiveness, not immediate safety risks.
Check the lot numbers on the product packaging: NP737, PG628, PY816, or NY939 with specific syringe blister lots and expiration dates.
We’ve drafted a message you can send Straumann to request your refund or repair — edit it as you like.
Subject: Recall Z-1693-2018 — Straumann Straumann Hello, I own a Straumann that is covered by recall Z-1693-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
