Straumann recalls Emdogain 0.3ml Multipacks due to unverified shelf life changes in raw materials. Affected lots expire by 11/30/2018 to 1/31/2020. Consumers should check lot numbers on packaging.
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 because a raw material's shelf life was changed without proper testing. This could affect product effectiveness if used after the expiration date.
The product's raw material shelf life was altered without sufficient evidence that the product remains effective. This could lead to reduced effectiveness if used after the expiration date.
People who own or use Emdogain 0.3ml Multipacks with lot numbers from NY938 to PY817 are affected. Those using the product for dental procedures are most at risk.
Check the lot number on the packaging: NY938, MN843, NP738, NE101A, PG629, NK216, PY817, or PT888C. The product expires by 11/30/2018 to 1/31/2020.
Look for lot numbers on the packaging: NY938, MN843, NP738, NE101A, PG629, NK216, PY817, or PT888C.
The recall is due to a change in the raw material's shelf life that wasn't properly tested for product effectiveness.
Check the lot number on the packaging. If it matches the affected lots listed, contact Straumann for further instructions.
The product may still be safe if used before the expiration date, but effectiveness could be reduced if the raw material's shelf life was changed without proper testing.
We’ve drafted a message you can send Straumann to request your refund or repair — edit it as you like.
Subject: Recall Z-1696-2018 — Straumann Straumann Hello, I own a Straumann that is covered by recall Z-1696-2018 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.
