TEI Biosciences recalls PriMatrix Meshed dermal repair scaffolds due to possible endotoxin test failures in manufacturing. Affected items have specific sizes and item numbers.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
TEI Biosciences is recalling PriMatrix Meshed dermal repair scaffolds because their endotoxin testing may not meet specifications. This could lead to potential health risks if the product is used improperly.
The recall is due to possible out of specification endotoxin test results in the manufacturing process. Endotoxins are substances that can cause adverse reactions in some patients, but the risk is not severe enough to cause serious injury in normal use.
Patients using prescription dermal repair scaffolds made by TEI Biosciences are affected. Those with specific sizes and item numbers listed in the recall are most at risk.
Check if your PriMatrix Meshed scaffold has sizes 20x25 cm, 3x3 cm, 4x4 cm, 5x5 cm, 6x6 cm, 8x12 cm, or 8x8 cm. Look for item numbers starting with 607-005-225 through 607-005-880.
Verify your PriMatrix Meshed scaffold's size and item number against the list provided in the recall.
The recall is due to possible out of specification endotoxin test results in the manufacturing process.
Sizes 20x25 cm, 3x3 cm, 4x4 cm, 5x5 cm, 6x6 cm, 8x12 cm, and 8x8 cm are affected.
Item numbers starting with 607-005-225 through 607-005-880 are affected.
We’ve drafted a message you can send TEI Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2079-2023 — TEI Biosciences TEI Biosciences Hello, I own a TEI Biosciences that is covered by recall Z-2079-2023 from TEI Biosciences. 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.
