Straumann recalls 32.5 oz KeyPrint Soft- resin bottles sold in the US with European labels. These resin bottles are used for dental appliances like mouthguards. The recall is due to incorrect labeling for the US market.
Product label intended for the European community was distributed to the USA market via their US distribution organization
Straumann is recalling 32.5 oz KeyPrint Soft- resin bottles sold in the US that have European labels instead of US labels. This could cause confusion for dental professionals using the product for orthodontic appliances.
The product label intended for the European market was distributed to the US market through Straumann's US distribution organization. This labeling error could lead to confusion about the product's specifications and usage in the US.
Dental professionals and orthodontists who use KeyPrint Soft- resin bottles for making mouthguards, nightguards, and dental appliances. Those who purchased the product with European labels are most at risk.
Check for the product label intended for the European community. The bottles have a model number 4220005 and lot number KJ2858 with an expiration date of April 22, 2023.
Look for the European label on the bottle instead of a US label.
The product label intended for the European community was distributed to the US market via their US distribution organization.
Model number 4220005.
Expiration date is April 22, 2023.
We’ve drafted a message you can send Straumann to request your refund or repair — edit it as you like.
Subject: Recall Z-2336-2021 — Straumann Straumann Hello, I own a Straumann that is covered by recall Z-2336-2021 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.
