Straumann recalls Emdogain 0.7ml Multipacks with potential shelf life issues. Affected items have specific lot numbers and expiration dates. Consumers should check their product details and contact Straumann for guidance.
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 0.7ml Multipacks due to a change in raw material shelf life without proper testing. This could affect product effectiveness over time. The recall does not involve immediate safety risks but requires checking product details.
The recall involves a change in the raw material's shelf life without sufficient testing to ensure the product remains effective. This could lead to reduced effectiveness over time but does not pose immediate safety risks.
People who own or use Emdogain 0.7ml Multipacks with specific lot numbers and expiration dates are affected. Those using the product for medical purposes may need to verify its effectiveness.
Check for the product name 'Emdogain 0.7ml Multipack' with lot numbers NZ535, LP632A, PG631, NE101B, PY818, or PT888A and expiration dates listed in the recall.
Identify your Emdogain 0.7ml Multipack's lot number and expiration date to see if it matches the recalled items.
No immediate safety risk is reported. The recall is about potential reduced effectiveness over time due to shelf life changes.
Check your product's lot number and expiration date. If it matches the recalled items, contact Straumann for guidance.
Look for lot numbers NZ535, LP632A, PG631, NE101B, PY818, or PT888A with the specified 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-1698-2018 — Straumann Straumann Hello, I own a Straumann that is covered by recall Z-1698-2018 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.
