TEI Biosciences recalls PriMatrix Dermal Repair Scaffold products due to possible out of specification endotoxin test results. These products are prescription-only and available in specific sizes.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
TEI Biosciences is recalling certain sizes of their PriMatrix Dermal Repair Scaffold products because endotoxin testing results may be out of specification. This could potentially lead to unsafe levels of endotoxins in the product.
The recall is due to possible out of specification endotoxin test results in the product. Endotoxins are substances that can cause adverse reactions in some individuals, especially those with sensitive medical conditions.
Prescription users of PriMatrix Dermal Repair Scaffold products are affected. Those using the product for medical purposes may be at risk if the endotoxin levels are unsafe.
Check for the product sizes: 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, or 8x8 cm. The item numbers include specific UDI-DI codes listed in the recall notice.
Review the product sizes and item numbers listed in the recall notice to determine if your product is affected.
The recall indicates possible out of specification endotoxin test results, so the product may not be safe. Users should check if their product is listed in the recall and follow the action steps.
The recall does not specify a remedy, so users should check the product details against the listed sizes and item numbers to determine if they are affected.
The recall mentions possible unsafe endotoxin levels, which could cause adverse reactions in some individuals, especially those with sensitive medical conditions.
We’ve drafted a message you can send TEI Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2077-2023 — TEI Biosciences TEI Biosciences Hello, I own a TEI Biosciences that is covered by recall Z-2077-2023 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.
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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.
